Medical Device Daily 9Spet2013 DenverProfilePgs1and6

MONDAY, SEPTEMBER 9, 201 3 VOL. 17, NO. 173 PAGE 1 OF 10

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INSIDE:Don’t miss today’s MDD Extra: Neurology

Regional innovation review

A decade of growth in metro Denver’s medical device sector By JEFFREY BERG, PhDMedical Device Daily Contributing Writer

The medical device sector in Metro Denver region has experienced dramatic growth over the past decade, including 16% growth during the years of recession, 2001-2010. This growth followed a report issued in March 2003 by the Governor’s office entitled “Colorado’s Place in the Sun: A Bioscience Future, An Action plan to Grow Colorado’s Bioscience Cluster.” Metro Denver currently ranks as the sixth largest cluster of medical device companies in the U.S. Over the past five years, the region has seen more growth in device companies than biotech or pharmaceuticals.

The Fitzsimons Redevelopment Authority (FRA) was created in 1996 by the University of Colorado (Boulder) and the city of Aurora. The FRA was given a single mission:

Cook launches LithAssistto aid in PCNL proceduresBy OMAR FORDMedical Device Daily Staff Writer

Cook Medical (Bloomington, Indiana) reported that it has developed a new device to simplify percutaneous nephrolithotomy (PCNL) procedures, during which physicians break up and remove large kidney stones, or can use it in the bladder to break up large bladder stones.

The company said that its LithAssist has already received the nod from the FDA and that last week was the formal launch of the device.

“We do have an FDA clearance for the device that we received earlier this year and we have a CE mark as well,” Rebecca Walendzak, director of global product management urology for Cook, told Medical Device Daily. “We’ll continue to work on registrations globally that align with our current markets that we sell products in. We’re just making this

Report from Europe

Fujifilm SonoSite gets CE mark for X-Porte kioskA Medical Device Daily Staff Report

Fujifilm SonoSite (Bothell, Washington), specialists in designing ultrasound tools and education for access to point-of-care visualization, reported CE mark approval of its newest generation of point-of-care ultrasound, the X-Porte ultrasound kiosk. Available in a stationary or a detachable use model, SonoSite said it will begin shipping the X-Porte kiosk immediately.

The company noted that the X-Porte kiosk was created to serve a broad spectrum of users, from novice to advanced, and represents an entirely new design and use paradigm for ultrasound.

“This is a major accomplishment for SonoSite and a defining moment in the next phase of our innovation

Washington roundup

Medicare panel refutes cost-to-charge rubric for imagingBy MARK McCARTYMedical Device Daily Washington Editor

The dust-up over the recent proposal to employ a set of 15 or more cost-to-charge ratios for Medicare imaging has resurfaced thanks to a panel that urged a delay in use of the practice for outpatient imaging pending a review by the panel. The development would seem to put the predicament back into play for inpatient imaging as well, and a trade association has indicated that policymakers on Capitol Hill are listening. The issue affects payments made in the calendar year, however, which gives Congress more time to address the matter than would be the case if the payment policies were applied to the upcoming fiscal year, which commences in roughly three weeks.

See Cook, Page 9

See Europe, Page 7 See Washington, Page 8

See Denver, Page 6

PHILIPS TO SUPPLY ULTRASOUND TO MCL’S CARDIO DEPT.. . . . . . . . 2ENZYMATICS IN ACQUISITION OF ARCHERDX FOR UP TO $50M. . . . . . 3

MONDAY, SEPTEMBER 9, 2013 MEDICAL DEVICE DAILY™ PAGE 2 OF 10

Agreements/contracts

Philips to supply ultrasoundto MCL’s cardio departmentA Medical Device Daily Staff Report


See Agreements, Page 4

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Royal Philips (Amsterdam, the Netherlands) and Medical Center Leeuwarden (MCL; Leeuwarden, the Netherlands) reported a long-term agreement. The partnership will give MCL continuous access to Philips’ ultrasound technology throughout its cardiology department for the next ten years. Philips will provide structural innovation upgrades and consultancy and training services, maintaining MCL’s access to the latest cardiac ultrasound technologies for routine and advanced diagnostic purposes and minimally-invasive interventional procedures.

Philips claims that MCL will be one of the first hospitals in the Netherlands to enjoy the benefits of Philips’ brand new EPIQ “anatomical intelligence” ultrasound imaging platform. This new managed services partnership will support innovative and affordable care in the Netherlands.

“Ultrasound imaging plays a fundamental and wide-spread role in cardiology, driven in part by innovations over the past decade that have dramatically increased its functionalities,” says Rob Breedveld, MD, cardiologists at Medical Center Leeuwarden. “It is important for us to collaborate with a partner that leads the way in technology innovation. Our close cooperation and long-term agreements with Philips make sure we have access to the latest innovations, such as the EPIQ ultrasound system, that further improve the way our staff can diagnose and treat patients, while also helping to manage costs.”

The flexibility and cost-effectiveness of ultrasound imaging means that it is widely used in virtually every phase of cardiac care, from diagnosis and treatment to patient monitoring. Because of its 3-D live-imaging capabilities and

inherent safety, it is increasingly being used as an additional modality for minimally invasive image-guided cardiac interventions such as heart valve repair/replacements, the company said.

Philips will install its ultrasound imaging solutions in many different parts of MCL’s cardiology department, including in its cardiac emergency department, catheterization lab, hybrid operating room, pediatric cardiology unit, coronary care unit and outpatient clinics.

Philips specializes in medical imaging and ultrasound.In other agreements/contracts:

The U.S. Defense Department (DoD) handed out 3 new healthcare contracts to Philips Healthcare (Amsterdam, the Netherlands) and Johnson & Johnson (New Brunswick, New Jersey), totaling a potential worth of nearly $73 million for medical equipment, according to massdevice.com.

In a contract report issued August 29, the DoD posted a $17. 1 million contract for Philips’ biomedical equipment and maintenance for Air Force and Army facilities. Philips won contract via an online competitive bidding acquisition that featured only 1 other unnamed rival, according to the DoD report.

Just a day later, the DoD announced another Philips contract worth a maximum of $46.3 million over 5 years for “multi-vendor maintenance services.” That contract, which is a fixed-price deal with economic price adjustment, was a competitive acquisition with 5 total offers, the defense agency said.

The feds also awarded a medical and surgical products contract to Johnson & Johnson, giving the deal a 1-year shelf-life and a maximum value of $9.6 million. J&J’s products will go to the Army, Navy, Air Force, Marine Corps and federal civilian agencies, according to the agency.

The Premier (Charlotte, North Carolina) healthcare alliance has awarded new agreements for hematology



Deals roundup

Enzymatics reports acquisition of ArcherDx for up to $50MA Medical Device Daily Staff Report

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Enzymatics (Beverly, Massachusetts) said it has acquired ArcherDx (Boulder, Colorado), a developer of NGS-based kits and software solutions for use in investigating cancer treatment. The deal consists of cash, equity and potential milestones worth up to $50 million.

Jason Myers, PhD, co-founder and CEO of ArcherDx, has joined Enzymatics as chief scientific officer. Enzymatics produces reagents, kits, and assays.

With the acquisition, the company adds genomic capabilities complementary to its Enzymatics Supply Chain Solutions and Enzymatics Reagents groups and greatly expands its new Enzymatics Diagnostics group with an innovative technology, kits and analytical software to provide hospitals, research institutions and other diagnostic providers with a total solution to rapidly and cost-effectively detect and assess genetic biomarkers. ArcherDx technology has several advantages in copy number variation and translocation analyses, and results are obtained quicker than current methods, offering a more cost effective approach to healthcare, Enzymatics noted.

“An unprecedented growth in genomics for healthcare is fueling greater demand for faster, more accurate, and more cost effective sequencing applications. We are seeing double-digit growth in the placement of new sequencers every year and broad adoption of genomic technologies across clinical communities. Enzymatics, which already supplies reagents and kits to approximately 80% of the NGS industry, together with ArcherDx, will bring novel sequencing applications more directly to clinical researchers,” said Jon DiVincenzo, Enzymatics’ president/CEO. “We are also truly excited to welcome Jason and his team of scientists and bioinformatics researchers to our rapidly growing company.”

In other dealmaking activity, Baxter International (Deerfield, Illinois) reported that the company has completed the acquisition of Gambro (Lund, Sweden), a global medical technology company that makes dialysis products, for roughly $3.9 billion. The transaction further enhances Baxter’s global renal leadership and provides the company with a comprehensive product and therapies portfolio to meet the needs of patients in the large and growing dialysis market, the company said.

Baxter said the transaction was financed through a combination of cash generated from overseas operations and debt issuances. The impact of the acquisition was included in the company’s third quarter and full year 2013 guidance.

“The combination of these two respected renal leaders – Baxter and Gambro – will enable Baxter to better serve healthcare providers and patients through a collective

offering of innovative renal products and therapies,” said Robert Parkinson, Jr, chairman/CEO of Baxter. “Together, we will advance the state of dialysis care for patients with kidney disease worldwide.”

The acquisition provides a number of long-term growth opportunities for Baxter around the world, the company said. With a broad and complementary dialysis product portfolio and global footprint, Baxter can accelerate product sales in established markets such as Europe, where Gambro has an extensive presence. Baxter will also expand Gambro’s reach in high-growth regions of Latin America and Asia-Pacific, where Baxter has steadily grown its peritoneal dialysis (PD) business. In addition, Baxter will build upon its core portfolio and pipeline of investigational home hemodialysis and automated PD systems by adding Gambro’s dialyzers, devices and dialysis solutions, highly innovative and next-generation monitors, and acute therapies to treat patients with serious kidney, liver and lung conditions.

Brik Eyre has been named president of the combined renal business and has been elected a corporate officer of Baxter by the company’s boards. Eyre joined Baxter in 2008 and previously served as the general manager of U.S. Medication Delivery. !

www.pacificbridgemedical.com



Financings roundup

Advance Medical raises $20M,acquires Brazilian companyA Medical Device Daily Staff Report

HIT roundup

GLNT expands telemedicine tech for Parkinson’s Disease A Medical Device Daily Staff Report

Great Lakes NeuroTechnologies (GLNT; Valley View, Ohio) said it is launching commercialization and clinical studies to expand their telemedicine technology, Kinesia HomeView, for individuals with Parkinson’s disease by adding real-time video conferencing. The research and development are being funded in part by a $1.2 million Phase II Small Business Innovative Research grant from the National Institutes of Health, National Institute on Minority Health and Health Disparities. The technology is currently under development at GLNT with clinical validation studies planned this fall domestically at The University of Rochester, The University of Toledo, and internationally at Hospital Universitario de Burgos in Spain. As part of development, GLNT is partnering with Vidyo (Hackensack, New Jersey) to integrate their real-time video conferencing technology into the Kinesia system.

GLNT currently provides remote monitoring for Parkinson’s with Kinesia HomeView. The system includes

patient-worn motion sensors and broadband integrated tablet which patients use to follow video instructions and complete motor assessments. All data is transmitted remotely to a HIPAA compliant server and clinicians login to a website to view symptom reports. Adding video conferencing will close the loop on clinical workflow by allowing clinicians to then remotely discuss the results with patients and offer recommendations that can improve their quality of life. “The clinical market, regulatory environment, and reimbursement landscape for telemedicine are all rapidly evolving and Parkinson’s disease is uniquely positioned to benefit from telemedicine”, said Joseph Giuffrida, PhD, president and principal investigator on this program. “Parkinson’s is an incredibly complex disease, and we are focused on developing remote monitoring technologies with visualization tools that can scale to the needs of patient care. Integrating remote monitoring with real-time video conferencing solves both the challenges of accurately capturing symptom response to treatments and accessibility of care, which are critical to improve quality of life for individuals with Parkinson’s. Commercially, the technology will position GLNT with a complete telemedicine solution for both clinical care and clinical trials markets.” !

Advance Medical (Palo Alto, California), a medical device, equipment, and diagnostics distribution company backed by U.S. and Latin American investors, said it has raised $20 million in an equity financing from new investors Aberdare Ventures and Arboretum Ventures, as well as existing investors including Venrock and Jose Bonchristiano.

The company also reported that it has reached a definitive agreement to acquire all of the outstanding shares of Imunotech Sistemas Diagnosticos (Sao Paulo, Brazil), a company that distributes medical and laboratory equipment and reagents.

Also, the company says it has added Hector Sobrino, MD, as general manager for its Mexico operations. Sobrino was previously at Sanofi where he spent seven years in commercial roles in Mexico as well as in other countries in Latin America. The company also added Claudia Goulart, former CEO of GE Healthcare for Latin America, to its board of directors.

“We are very fortunate to have top U.S. venture investors lead our Series B round and to combine with Imunotech, a company and team with a long and distinguished commercial track record. Our expanded team, and combined resources and capabilities, greatly enhance our ability to become the Latin American commercial partner-of-choice for innovative

companies globally,” said Fred Aslan, MD, the company’s founder/CEO.

In other financings activity, Tenet Healthcare (Dallas) is offering to sell $2.8 billion aggregate principal amount of senior unsecured notes and $1 .8 billion aggregate principal amount of senior secured notes through a private placement. The secured notes will be guaranteed by and secured by a pledge of the capital stock and other ownership interests of certain of Tenet’s subsidiaries. The proceeds from the offering will be used to finance in part Tenet’s pending acquisition of Vanguard Health Systems (Nashville, Tennessee), including the refinancing of certain of Vanguard’s existing indebtedness.

Tenet is a healthcare services company, and, through its subsidiaries, operates 49 hospitals, 132 outpatient centers and Conifer Health Solutions, a leader in business process solutions for healthcare providers. !

analyzers, automation, reagents, consumables and service to Abbott Laboratories (Abbott Park, Illinois); Beckman Coulter (Brea, California); and Sysmex America (Lincolnshire, Illinois).

The agreements with Abbott Laboratories and Sysmex America are available to acute care and continuum of care members of Premier. The agreement with Beckman Coulter Inc. is available to hospital market facilities.

Premier operates a purchasing network and maintains clinical, financial and outcomes databases. !

AgreementsContinued from Page 2



(Raleigh, North Carolina) has named William Cromwell, MD, as chief medical officer. Cromwell is an internationally recognized expert in the management of lipid and lipoprotein disorders. He joins LipoScience for a second time, having previously served as the company’s chief medical officer from 1999 – 2005. LipoScience is a diagnostic company specializing in personalized NMR diagnostics for cardiovascular, metabolic and other diseases.

(Caesarea, Israel) said Christopher Prentice has been promoted to senior VP, America & Global Marketing. Prentice joined Mazor in 2010 and has spent the past 15 years in healthcare management with a focus on advancing new technologies in surgery. Mazor Robotics makes the Renaissance surgical guidance system.

(Auckland, New Zealand) reported three appointments to its senior management team. Veronique Bouchet has joined as VP of business development for Europe, Christopher Stevens has been named as chief operating officer, and Chris Mander has taken on the role of head of regulatory and quality. Bouchet has industry experience and has held a variety of senior international roles across several therapeutic areas and functions, including strategy, drug development, business development and M&A, most recently with AstraZeneca. Stevens previously was chief technology officer for Orion Health. Mander has more than 20 years of experience from the respiratory medical device and patient monitoring sectors. Nexus6 is a digital health company dedicated to improving respiratory care.

(Madison, Wisconsin) has named Raymond Heller as executive VP of sales and marketing. Previoulsy, Heller was executive VP of sales at Ohio Medical. Swallow Solutions’ clinically tested therapy protocol is designed to strengthen and improve swallowing capabilities for adults who experience symptoms of dysphagia. The company makes the Madison Oral Strengthening Therapeutic device, which is an adjustable mouthpiece equipped with feedback sensors.

People in the News

Product Briefs(Greenwich, Connecticut) says

a newly published peer-review study on Stretta therapy is bringing renewed attention to this non-surgical procedure that has 10 years of patient data and recently earned The Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) highest GRADE recommendation. The study, published in Gastroenterology Research and Practice, is titled “Stretta Radiofrequency Treatment for GERD: A Safe and Effective Modality” and presents facts that dispel some misconceptions about Stretta. The study concludes that Stretta is a safe and effective treatment in patients for whom PPI therapy is undesirable, or the many that prefer less invasive treatment options. Stretta uses low power and low temperature radiofrequency (RF) energy to remodel the lower esophageal sphincter muscle, thus reducing Gastroesophageal Reflux Disease (GERD) and its symptoms. Stretta is a minimally invasive treatment for GERD that is an effective option for patients who do not respond well to medications. Stretta involves delivery of RF to the LES and gastric cardia. Studies show Stretta is a safe, effective and durable therapeutic option. Stretta does not preclude further steps with more invasive procedures if indicated. Stretta is currently covered by many insurance plans. Mederi Therapeutics makes medical devices that deliver RF energy to treat diseases of the digestive system.

(Columbia, Maryland) said its multi-center, randomized, controlled clinical trial evaluating the safety and effectiveness of Grafix for the treatment of chronic diabetic foot ulcers has been accepted for podium presentation at the upcoming Symposium on Advanced Wound Care (SAWC) in Las Vegas. Larry Lavery, MD, Principal Investigator and Professor of Plastic Surgery at the University of Texas Southwestern Medical Center, will discuss the primary and secondary endpoints as well as additional key safety data from the trial. Grafix is a human cellular repair matrix containing living stem cells for acute and chronic wound repair. It is a flexible, conforming membrane that provides a high quality source of living mesenchymal stem cells (MSCs) and growth factors directly to the site of the wound. Grafix is produced by BioSmart Intelligent Tissue Processing of human placental membrane. The manufacturing process maintains the integrity of the extracellular matrix, the viability of the neonatal MSCs, and the biologically active growth factors. In August, Osiris reported that the trial had reached the pre-specified stopping rules for overwhelming efficacy. Additionally, the trial demonstrated that Grafix closed wounds faster and required fewer treatments, with fewer adverse events than standard treatment.

(Frankfurt, Germany) recalled 78,020 microbiology testing panels in the U.S. as they are reporting

false results, U.S. health regulators said. The defect found in certain MicroScan panels may lead to treatment of patients with inappropriate antibiotics or to a delay in the therapy they need, the FDA said on its website. The MicroScan recall was classified as the most serious type of recall - one that involves situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death. Siemens said the matter impacts only a small number of its customers, all of whom have been notified and instructed on how to respond. It said it was taking unspecified corrective action for the affected panels.



DenverContinued from Page 1

to imagine and govern the evolution of a historic army medical center into one of the world’s most forward-looking bioscience districts. The result is the creation of the Anschutz Medical Campus (Aurora) which includes: Children’s Hospital, University of Colorado Hospital, the university’s medical, nursing, dental and pharmacy schools, and the Colorado Science + Technology Park. A new Veterans Administration hospital is also under construction at this site. Steve VanNurden, President and CEO of FRA, assumed this position in May 2012. He was previously chair of Mayo Clinic Ventures (Rochester, Minnesota). He defined the aim of the FRA as providing the infrastructure needed to attract life science companies to settle in close proximity to academic sources of technology and to stimulate commercialization.

The Colorado BioScience Association (Denver) is at the forefront of Colorado’s bioscience growth. It supports the state-wide bioscience community through advocacy, resources and advancement of opportunities for collaboration. April Giles, the association’s President & CEO, told MDD that it “aims to help companies from concept to commercialization, to create networks and resources to help companies in planning their business and in understanding how federal and state guidelines and policies have implications in their business.” She referenced the BioFrontiers Institute at the University of Colorado in Boulder which conducts research in regenerative medicine and has programs in areas related to stem cells, biomaterials, tissue engineering, drug delivery, optical imaging, and cellular biomechanics. Ms. Giles cited Touch of Life Technologies (Aurora) as an example of a successful spinoff from the University of Colorado. It provides human models that serve as medical simulators for virtual reality-based training of medical skills through a single hardware platform.

The Colorado BioScience Association hosts the Rocky Mountain Life Science Investor & Partnering Conference which will be held in Denver September 18 and 19 and covers the fields of biologics, medical devices, drug delivery and diagnostics. Presentations will be made by companies in Colorado, Arizona, Utah, New Mexico and Montana. Ms. Giles said “we think that this region is significantly underserved as far as investment opportunities are concerned.”

The Colorado Institute for Drug, Device and Diagnostic Development (CID4 ; Aurora) was formed in November 2009 with funding from federal and state sources and from the FRA. CID4 is a not-for-profit organization that receives research proposals which are reviewed by an advisory committee. A total of 120 technologies have been screened to date and 8 were selected for investment. The CID4 also provides mentoring to an additional 50 companies it which it has not invested. Several of these companies are housed at The Colorado Science + Technology Park which serves as an incubator for startups.

Kevin Smith, president/CEO of CID4, noted that “we are trying to do economic development through innovation advancement and we’ve had success in commercializing early stage technologies by company formation. Evidence of that success is the number of companies that have been acquired over the past decade. We are looking to find a way to retain their corporate headquarters after their acquisition.”

Metro Denver Economic Development Corporation (Denver) covers 9 counties with a population of 3 million people. Its mission is to create the environment and infrastructure that goes with it and to create industry clusters. According to Tom Clark, CEO, “the achievement of regional competitiveness comes from not trying to recruit a few ‘hot’ companies to an area, but by creating a self-sustaining economic ecosystem that is not primarily dependent on outside infusions of money and investment. He cited a study by the Brookings Institution (Washington, DC) which found that Metro Denver is the number one region in the U.S. for people ages 25 to 34 to relocate.

High Country Venture (Boulder) is one of only a few venture firms in Metro Denver that invests in life science companies. It was founded in 2004 and invests only in Colorado-based firms, several of which are spinoffs from the University of Colorado which has four campuses, with the largest student body on the Boulder campus. Mark Lupa, Managing Partner, told MDD that “the area is totally underserved from a venture capital point of view. There are many very high quality venture capital opportunities that can be funded. Our problem is that companies grow up here then get acquired and move on, but that produces a large number of people with experience in taking companies from an early stage to acquisition.”

High Country Venture’s investments are in the range of $750,000 to $1 million, with a maximum of $4 million over the life of a company. There are 9 life science companies in its portfolio including Mosaic Biosciences (Boulder) which is developing a new class of synthetic polymer matrices to support native tissue regeneration with potential applications in the fields of wound healing, bone regeneration, cartilage repair, stem cell therapy and cosmetic surgery, and EndoShape (Boulder) which is developing the Medusa vascular plug made from a shape memory polymer (SMP) for use in embolization and occlusion. SMP was licensed from the University of Colorado and is based on the research of professor Robin Shandas, PhD, the founder of EndoShape and Chair of the university’s Department of Bioengineering. !

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EuropeContinued from Page 1strategy,” said SonoSite President/CEO Kevin Goodwin. “Once again, our engineering team has achieved the creation of a remarkable new tool built from the ground up.”

The company said the X-Porte kiosk is an important milestone in SonoSite’s ongoing effort to improve access to point-of-care ultrasound visualization. According to SonoSite, the foundational advancement behind X-Porte is a new imaging technology never before used in ultrasound systems: SonoSite’s proprietary Extreme Definition Imaging (XDI) technology.

XDI was created following 35 years of applied ultrasound research by the company’s chief technology officer, JJ Hwang. XDI is designed to significantly reduce visual clutter from side-lobe artifacts that affect all ultrasound imaging regardless of system size.

“I believe this reduction in visual clutter sets a new bar in point-of-care image quality,” said Hwang, who describes the XDI technology as “an entirely new way to create an ultrasound image.” He added that it allows the user to realize much higher resolution.

To maximize the utility of the XDI technology, X-Porte delivers optimum usability and interoperability through its groundbreaking visual learning guides. The kiosk integrates high-resolution ultrasound imaging synchronously with 3-D animations that enable “any user, any time of day” to make the most of the operating the technology. These learning modules can be used simultaneously with live scanning to optimize in-the-moment performance and user consistency.

“The design genesis is aimed at enabling any and all members of a healthcare team—nurses, mid-level providers, and even a physician-hospital administrator—to be empowered to take advantage of X-Porte’s high-performance visualization,” Goodwin said.

SonoSite says it partnered with world-leading product designers and experts in advanced automotive animation modeling and distance medical learning. To ensure maximized clinical efficacy, a consortium of expert physician educators contributed their expertise for each 3-D application module.

The team also designed a unique, multi-touch, gesture-driven user interface comparable to those found in the consumer world. With personalization capability by any user, controls can be repositioned with the glide of a hand and without keys or buttons.

The highly cleanable, sealed user interface was designed with minimal crevices to facilitate optimal infection control. The glass surface has been tested against incidental spills and allows cleaning with a wide range of disinfectants without deteriorating the surface over time.

“We combined their many insights with the most innovative consumer technologies available today, then we blended in our own inspiration from key engineers at our company,” Goodwin said.

Apica gets CE mark for ASCApica Cardiovascular (Galway, Ireland) said it has

received CE mark approval for its platform Access, Stabilization, and Closure (ASC) system that allows for the delivery of aortic and mitral valves through the chest wall and apex of the beating heart.

According to the company, the ASC system is a platform technology that can be used by surgeons, in conjunction with minimally invasive surgical techniques. It delivers large-bore therapeutic devices into the beating heart of patients with structural heart disease, via the apex. The ASC system is designed to both seal and stabilize the tissue of the access site during therapeutic device delivery, minimizing loss of blood from or induction of air to the beating heart. On completion of the therapeutic treatment, it is designed to standardize apical access and closure, leading to safer heart operations, decreased procedure time and reduced technical challenges associated with transapical access and closure.

CE mark approval for the ASC system was based on meeting all safety and technical performance endpoints in a multi-center clinical trial conducted in Germany at the Kerckhoff Klinik (Bad Nauheim), University Heart Centre (Hamburg), and the Heart Centre (Leipzig). The ASC system demonstrated an excellent safety profile with 100% technical success, superior ease-of-use for surgeons, and reductions in both blood loss and operative time, the company noted. Follow-up assessments of patients showed that the system provided robust closure, with no post-operative apical bleeding complications and no degradation of left ventricular function, Apica added.

“Clinically, the Apica ASC system is easy to use, standardizing apical access and closure. Its sutureless access coil minimizes both rib spreading and patient pain, providing a dry access site with no peri-sheath bleeding during the TAVI procedure,” said Thomas Walther, MD, the study’s principal investigator and a pioneering surgeon in the field of TAVI based at the Kerckhoff Klinik. “Apical closure was reliable, rapid, and completely dry, demonstrating a reduction in operative times, blood loss, use of blood products and apical access site complications.”

The ASC system was initially developed as a result of collaboration between Apica and a team at Emory University and the Georgia Institute of Technology (both Atlanta), led by Drs. Jorge Jimenez, Vinod Thourani and Ajit Yoganathan. Following initial Series A joint investment by Triventures, an Israeli-based venture capital company and Seroba Kernel Life Sciences, a European venture capital company based in Ireland and the UK, Apica was established in Galway, Ireland and began developing the ASC system in early 2011.

Following CE mark approval, the ASC system will now be selectively launched into specific specialist TAVI centres across Europe, with the focus on safety, technical

See Europe, Page 9



WashingtonContinued from Page 1

The Centers for Medicare & Medicaid Services indicated in its FY 2014 inpatient prospective payment system (IPPS) draft that it had enough hospital data to round out a full set of cost-to-charge ratios (CCRs) for CT and MRI, which gives the agency a means of recalculating relative weights for these two modalities (Medical Device Daily, April 30, 2013). The agency subsequently indicated an interest in employing the same methodology to calculate relative weights for outpatient imaging as well, which triggered the evaluation by an advisory panel for outpatient payment.

The hospital outpatient payment panel released a summary of its recommendations, which include the suggestion that CMS delay implementation of the CCR calculations “until data can be reviewed by the panel at its spring 2014 meeting.” The panel stated that it would address “interactions between the proposals and their potential cumulative impact” in that spring meeting.

The Medical Imaging & Technology Alliance (MITA; Arlington, Virginia) argued in July that the CCR move would create sufficient reimbursement pressures to blunt patient access and could produce payment levels for various modalities that defy the substantial differences in cost (MDD, July 19, 2013).

Brian Connell, director of government relations at MITA, told Medical Device Daily that MITA is not ignoring the inpatient side of the discussion, but he said the focus at present is “on the finalization of the outpatient payment rule.”

“We are excited to have validation of our concerns coming from the [hospital outpatient] panel,” Connell said, adding that other stakeholders who are commenting are “echoing our concerns. We’re very hopeful CMS will respond appropriately in the final [outpatient] rule,” he said.

Connell indicated the inpatient situation is a concern, but said, “right now, the inpatient is a final rule. I think we have to wait and see after the outpatient final rule before we see what the next steps are” for the inpatient predicament.

Congress has weighed in on imaging issues frequently since the Deficit Reduction Act of 2005, and Connell indicated that the current situation also has the attention of policymakers on Capitol Hill.

“We’ve already seen that they’re concerned about this policy,” Connell said. “When you walk them through what CMS is doing and the practical impact on payment rates, people are very concerned,” he said.

Connell highlighted one of the more peculiar effects purported to be associated with the new CCR rubric, stating, “when you’re paying the same for an X-ray of the head as for a CT of the head, there’s something obviously wrong with that equation.” He said some on the Hill are “voicing those concerns to CMS, asking tough questions,” such as “how they arrived at that and how they’re going to fix it.”

When asked whether the CCR issue calls for a statutory fix, Connell said, “we’re hopeful that the draft proposal will

be dropped by CMS in the final rule, which would require no formal congressional action.” Connell added that any proposal “that pays the same for services that inherently cost different amounts and provide different diagnostic power simply doesn’t make sense. When we look at the end of the equation” as encoded in the outpatient rule, “you find payments that lack face validity.”

CMS has been working on the CCR problem for imaging for several years, which tackles a complicated cost issue for hospitals in that capital-intensive services lend themselves less readily to accurate accounting than more discrete services, such as device implants. Connell acknowledged that the matter is “a very complex issue,” but said much of the data available to CMS are “not designed to be used in the way CMS is attempting to use them.”

FDA; Siemens MicroScan a class I recallFDA reported that the recall of the Siemens MicroScan

plus and MicroScan rapID/S plus negative panels is a class I recall due to reports of false susceptible and false intermediate results for imipenem and meropenem antimicrobial susceptibility testing. The panels are used in conjunction with the MicroScan WalkAway system, and the FDA announcement indicated that the problem “may lead to treatment with an inappropriate antibiotic or a delay in initiating appropriate therapy.”

Siemens Healthcare Diagnostics (West Sacramento, California) initiated the recall Aug. 21, an action that affects more than 78,000 panels distributed in the U.S. between July 11, 2011 and Aug. 2, 2013. FDA states that Siemens has instructed users to “suppress all reporting of sensitive and intermediate results for imipenem and meropenem,” and that the firm also recommends customers “consider the need to review previous test results, conduct patient follow-up, and/or repeat testing.”

CMS eyes hepatitis C screeningThe Centers for Medicare & Medicaid Services announced

Sept. 5 it is considering a request for coverage of screening for hepatitis C and is accepting comments through Oct. 5. The agency indicated the request came from within CMS and said that it expects to render a decision by March 5, 2014.

One commenter pointed to a recent article in the Aug. 28 online edition of the Journal of the American Medical Association, which reviews a randomized trial for sofosbuvir and ribavirin for hepatitis C in patients with genotype 1. The single-center study evaluated the use of these agents in patients “with unfavorable treatment characteristics,” the abstract says, using an endpoint of sustained virological response at 24 weeks. According to the abstract, the trial returned a 24-week response of 68% for sofosbuvir and 48% for weight-based or low-dose ribavirin. !

Mark McCarty, [email protected]



CookContinued from Page 1

EuropeContinued from Page 7

available in the North American market and we’ll continue to roll out to additional markets throughout the month.”

LithAssist has the potential to impact the nearly 67,000 PCNL procedures are performed each year in the U.S., and the 466,000 that are performed globally.

“This product addresses a significant need,” Jean-Marc Creissel, global leader of Cook Medical’s Urology division told MDD. “It’s the first and only device of its kind that couples laser fiber access with manual suction control. Up to now the suction control was managed by a nurse. With this technology the physician would control everything, the positioning of the laser fiber as well as the suction.”

He added, “We could compare that to someone being in a car and one person would have the wheel and one would have the pedal. With this device, you have one driver.”

Prior to the availability of LithAssist, an assistant controlled suction by kinking a tube, similar to how one would stop water flow from a garden hose. LithAssist allows physicians to control suction more easily during the procedure. The ergonomic handle allows the physician to position the laser fiber and suction with one hand. Not only does this synchronize the procedure by giving the physician more control, but it also can free an assistant to help with other aspects of the procedure.

“Our goal for this product is to help physicians use their lasers for PCNL procedures in a simple way,” said Creissel in a release. “Streamlined procedures are beneficial for the physician, the hospital and ultimately the patient. This is just one more example of our commitment to solving problems for physicians.”

The company said that the LithAssist works with any holmium laser, so hospitals can use their current equipment and don’t have to purchase any additional capital equipment.

Cook said that the device is receiving a positive reception from physicians.

“With a procedure like this, there’s constant irrigation coming in and constant suction going out and the timing of that is something the physician wants to have control over,” Walendzak said. “Giving the physician the ability to have control over that suction is something they’re very excited about. It helps them to be able to more effectively treat the stone with the laser and control where that stone is going. They have to have irrigation to keep that visual field open but there’s also a manner in which if suction is too rapid, you’re going to interfere with the process. So they’re very excited about the precision and control this device gives them during the surgery.”

Cook would neither confirm nor completely rule out the possibility if it would seek approval for the device for additional indications.

“For us right now, this device is approved for urological indications, but we have seen the adoption of products and interest from other specialties and that’s something Cook

would partner with physicians to continue to work on...” Walendzak told MDD. !

Omar Ford; [email protected]

performance and cost-effectiveness.In parallel with the limited clinical European launch

of the ASC system, Apica is continuing to develop its next-generation devices for TAVI, as well as its Universal Port Access System for minimally invasive delivery of left ventricular assist devices without the need for cardiopulmonary bypass in the treatment of congestive heart failure.

Collaboration accelerates ultrasound The Focused Ultrasound Foundation (Charlottesville,

Virginia) and Royal Philips (Amsterdam, the Netherlands) have entered into a public-private collaboration with The Institute of Cancer Research (ICR; London) and The Royal Marsden NHS Foundation Trust. The partnership will create a focal point for ultrasound therapy research at the ICR and The Royal Marsden (London) under the international Focused Ultrasound Foundation Centers of Excellence Program.

The new initiative is intended to create a resource for clinicians and scientists working on high intensity focused ultrasound therapy, developing clinical evidence in oncology and establishing best practices, treatment standards and protocols. Focused ultrasound concentrates ultrasound energy with high precision on target tissue in the body to thermally destroy tissue. The technology is coupled with image guidance to identify, target and track the treatment in real time. The initiative will launch this autumn with a clinical trial to evaluate treatment of bone metastases in cancer patients. A similar center was established at the University of Virginia (Charlottesville) in 2009 to advance the use of focused ultrasound, with an emphasis on brain disorders.

The Focused Ultrasound Foundation is the catalyst for the collaboration and its leadership will actively engage with the ICR, The Royal Marsden and Philips to help guide progress towards standard-setting translational and clinical research, training and treatment. In establishing the Focused Ultrasound Centers of Excellence Program, the Foundation brings together the best people and resources at luminary research sites throughout the world in the dynamic multi-disciplinary environment necessary to foster those activities critical to accelerating progress towards better patient outcomes.

The center will be led by Gail ter Haar and Nandita deSouza. Ter Haar heads the ICR’s therapy ultrasound team. deSouza is the new initiative’s clinical director. !



Med-Tech Notes

Spectrum Plastics is now NPI Medical The Ansonia, Connecticut, division of Spectrum

Plastics Group (New Haven) has changed its name to NPI Medical to better reflect its core business.

Under the same ownership, NPI Medical will focus on providing solutions to its customers’ New Product Introductions (NPI), especially in the medical device market. “We have demonstrated our capability in new product introductions by helping our customers rapidly launch dozens of new medical device related products in the past few years. Speed to market is critical to our customers’ success and we have all of the internal capabilities to meet their needs,” said NPI Medical president Randy Ahlm. The company is investing in additional cleanrooms, new machines and additional automation to better serve its current and prospective customers.

NPI will continue to operate out of its 66,000-square-foot facility in Ansonia. The company’s senior management team remains the same and the experienced team of 85 associates will continue in their current roles, meaning uninterrupted service for current customers. The facility has multiple production cells arranged to help customers quickly move from prototype to production, including quick turn manufacturing for short runs, production injection molding for high volume programs, a full service tool room and multiple clean rooms.

BioReliance opens new facility in RockvilleSigma-Aldrich’s (St. Louis) BioReliance, the biologics and

early-development services business under SAFC, has opened a new clearance services facility in Rockville, Maryland. This facility, commissioned on Aug. 1, allows BioReliance to offer increased capacity and flexible scheduling while maintaining its core focus on providing industry-leading quality, expertise and value. The new U.S. facility more than doubles the amount of space available to clients to conduct their critical downstream bioprocessing studies.

Designed with input from clients and built to complement BioReliance’s global viral clearance services capabilities, the Rockville facility features four large clearance suites with modular layouts that allow for customized laboratory setups. All studies performed at the facility are completely secure and supported by dedicated scientists and state-of-the-art chromatography equipment, such as GE Healthcare’s AKTA avant.

“Combining our deep knowledge and proven experience with a global investment in modern facilities and equipment enables BioReliance to offer robust validation packages and proprietary CompleteClearance services to our clients. It’s all about simplifying the viral clearance process through an unrivaled combination of scientific expertise, client-

focused service and decades of experience,” said Archie Cullen, president of BioReliance. “Any time a client comes to work with us, they are assured that their study is expertly designed and performed by personnel that have participated in thousands of successful studies in support of clinical and commercial biopharmaceutical products.”

Sigma-Aldrich acquired BioReliance in January 2012.

Casa Grande deploys Radar managementRadar Medical Systems (Chagrin Falls, Ohio), a

division of RadNet (New York), said that Casa Grande Regional Medical Center (Casa Grande, Arizona) has implemented Radar for Critical Test Results Management.

Prior to deploying Radar, which provides automated, secure delivery, receipt and confirmation of any type of healthcare communication, Casa Grande used a manual system to contact referring physicians and to track results of those communications.

Toan Bui, RIS/PACS Administrator at Casa Grande, notes that a more secure process is a strong advantage on the compliance front. “We have proof that we have contacted our referring doctors, and we can run HIPAA-compliant reports in seconds,” Bui said. “Not only can we track communication activity in RADAR, as opposed to a spreadsheet, we can also measure the productivity gains we’re making.”

BP monitors set for stable market growth The world market for blood pressure monitors will

enjoy steady growth in the years ahead as aging populations climb in number and diseases exacting their toll require observation and supervision, according to a new report from IHS (Austin, Texas).

Global revenue for blood pressure monitors is set to reach $854.9 million by year-end, up a modest 2 percent from $838.8 million in 2012. Revenue expansion will hold firm at the 2% to 3% range for the next three years, before bounding to a 5% increase by 2017. By then, industry takings will amount to $963.2 million, as shown in the attached figure. The majority of revenue will stem from automatic upper-arm monitors, which is the preferred type of blood pressure monitor.

“One important reason for the consistent rise in revenue over the years is that the worldwide population of those aged 65 and above will continue to grow over time, making up an increasingly larger percentage,” said Roeen Roashan, analyst for consumer medical devices and digital health. “As a result, health monitoring will increase, which will drive market growth for blood pressure monitors. While evident in all regions, the phenomenon will be particularly apparent in Europe and Asia.”

Overall, blood pressure monitors will be part of an $8.2 billion market this year for consumer medical devices including blood glucose meters, activity and heart-rate monitors, and hearing aids. By 2017, total revenue for consumer medical devices will equate to a staggering $10.6 billion.

Keeping you up to date on recent developments in neurology

New laser-based tool could dramatically improve the accuracy of brain tumor surgery . . . A new laser-based technology may make brain tumor surgery much more accurate, allowing surgeons to tell cancer tissue from normal brain at the microscopic level while they are operating, and avoid leaving behind cells that could spawn a new tumor. In a new paper, featured on the cover of the journal Science Translational Medicine, a team of University of Michigan Medical School (Ann Arbor) and Harvard University (Cambridge, Massachusetts) research-ers describes how the technique allows them to “see” the tiniest areas of tumor cells in brain tissue. They used this tech-nique to distinguish tumor from healthy tissue in the brains of living mice – and then showed that the same was possible in tissue removed from a patient with glioblastoma multiforme, one of the most deadly brain tumors. Now, the team is working to develop the approach, called SRS microscopy, for use during an operation to guide them in removing tissue, and test it in a clinical trial at U-M. On average, patients diagnosed with glioblastoma multiforme live only 18 months after diag-nosis. Surgery is one of the most effective treatments for such tumors, but less than a quarter of patients’ operations achieve the best possible results, according to a study published last fall in the Journal of Neurosurgery. “Though brain tumor surgery has advanced in many ways, survival for many patients is still poor, in part because surgeons can’t be sure that they’ve removed all tumor tissue before the operation is over,” says co-lead author Daniel Orringer, MD, a lecturer in the U-M Department of Neurosurgery who has worked with the Harvard team since a chance meeting with a team member during his U-M residency.“We need better tools for visualizing tumor during surgery, and SRS microscopy is highly promis-ing,” he continues. “With SRS we can see something that’s invisible through conventional surgical microscopy.” The SRS in the technique’s name stands for stimulated Raman scattering. Named for C.V. Raman, one of the Indian scientists who co-discovered the effect and shared a 1930 Nobel Prize in physics for it, Raman scattering involves allows researchers to measure the unique chemical signature of materials. In the SRS technique, they can detect a weak light signal that comes out of a material after it’s hit with light from a non-invasive laser. By carefully analyzing the spectrum of colors in the light signal, the researchers can tell a lot about the chemical makeup of the sample. Over the past 15 years, Sunney Xie, PhD, of the Department of Chemistry and Chemical Biology at Harvard University – the senior author of the new paper – has advanced the technique for high-speed chemical imaging. By amplifying the weak Raman signal by more than 10,000 times, it is now possible to make multicolor SRS images of living tissue or other materials. The team can even make 30 new images every second – the rate needed to create videos of the tissue in real time. A multidisciplinary team of chemists, neurosurgeons, pathologists and others worked to develop and test the tool.

Brain clues reveal risk of psychotic illness . . . New research has shown that people with psy-chotic illness show similar brain changes to immediate family members who present no signs of illness. In a study detailed in the journal JAMA Psychiatry, researchers at Monash University (Victoria, Australia), in collaboration with The Univer-sity of Melbourne in Australia and the University of Cambridge in the UK, found that these brain changes represent a marker of genetic risk of developing psychotic illnesses, such as schizophrenia. Lead researcher, Alex Fornito, Deputy Director of Monash Clinical and Imaging Neuroscience in the School of Psychology and Psychiatry, said these genetic mark-ers could be targeted in the development of new treatments that may help to reduce the risk of developing psychotic ill-ness. “First-degree relatives of people with psychosis are at increased genetic risk of developing a psychotic illness,” For-nito said. “We have found that people with psychosis and their unaffected first-degree relatives, who otherwise present no signs of illness, show similar brain changes when compared to healthy people.” Fornito said even at the earliest signs of illness, patients showed altered activity (when compared to healthy people) in a specific brain circuit that links a region deep in the brain called the striatum with the prefrontal cortex. This circuit plays an important role in attention, learning and memory. “The fact that we see the same brain changes in this group, in the absence of any overt signs of illness, points to a neural biomarker of risk for psychosis.” The study examined 19 young people experiencing their first episode of psy-chotic illness and 25 of their unaffected parents or siblings. A group of 26 healthy unrelated participants was also recruited to draw comparison. The researchers used magnetic resonance imaging, or MRI, to map the activity of different brain sys-tems. The study also found a change in brain activity that was specific to patients but not their relatives. Associate Profes-sor Fornito said this change may reflect a ‘switch’ that determines whether a person transitions from an at-risk state to full-blown illness. “We know that activity in brain circuits linking the striatum and prefrontal cortex are heavily influenced

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by the neurotransmitter dopamine, which is a major target for all medications currently used to treat psychosis,” Fornito said. “The difficulty is that these drugs have rather diffuse effects on the brain, affecting many different systems. They also often have unpleasant side effects. Our findings point to a more specific treatment target. We are currently investigating whether we can selectively improve activity patterns in the affected brain circuits using non-invasive magnetic stimulation techniques. If successful, using these techniques in at-risk populations may help delay, minimise or prevent the impact of psychosis onset.”

Faulty recycling by brain’s trash collectors may contribute to Alzheimer’s . . . A defective trash-disposal system in the brain’s resident immune cells may be a major contributor to neurodegenerative disease, a scientific team from the Stanford University School of Medicine (Palo Alto, California) has found. Prelimi-nary observations show that this defect appears in the brains of patients who died of Alzheimer’s disease, so correcting it may someday prove to be an effective way of preventing or slowing the course of the disease. “We were fortunate in being able to compare microglia – the brain’s own immune cells – from five patients who died of Alzheimer’s disease with five who died of other causes,” said Tony Wyss-Coray, PhD, professor of neurology and neurological sciences at the medical school and senior research career scientist at the Veterans Affairs Palo Alto Health Care System. “And we discovered that in Alzheimer’s disease, the microglia are defective. One of these cells’ main functions, removing garbage, is impaired.” Wyss-Coray is the senior author of the study, which will be published Sept. 4 in Neuron. The lead author was postdoctoral scholar Kurt Lucin, PhD. Microglia, one of several important cell types in the brain, serve as both cops and trash collectors. These immune cells continuously police the brain, making sure everything is running smoothly. When they sense a patho-gen, they pull out the molecular equivalent of a pistol. If they spot a dead cell or a clump of protein detritus, they don a pair of overalls and hasten to remove it. They do this by engulfing and ingesting the target in a process called phagocytosis. Many cells can do this, but microglia are the pros – and they’d better be, said Wyss-Coray. “If they don’t clear up all the detritus in the brain efficiently, debris left lying around can trigger inflammation and consequent injury to neurons.” Pro-teins called phagocytic receptors on the surface of microglia look out for characteristic earmarks of detritus, dead cells and potentially toxic substances such as A-beta, a protein widely implicated in Alzheimer’s disease. A-beta is prone to clump into plaques that abound in the brains of people with Alzheimer’s and, to a lesser extent, in the rest of us as we grow older. When a targeted protein or piece of cellular debris is bound by a phagocytic receptor, part of the microglial cell’s outer membrane forms a bubble that encloses the target, migrates inward and fuses with the cell’s high-powered digestive machinery, which breaks down the ingested contents.

Discovery helps to unlock brain’s speech-learning mechanism . . . University of Southern California (Los Angeles) scientists have discovered a population of neurons in the brains of juvenile songbirds that are necessary for allowing the birds to recognize the vocal sounds they are learning to imitate. These neurons encode a memory of learned vocal sounds and form a crucial (and hitherto only theorized) part of the neural system that allows songbirds to hear, imitate, and learn its species’ songs – just as human infants acquire speech sounds. This discovery will allow scientists to uncover the exact neural mechanisms that allow songbirds to hear their own self-produced songs, com-pare them to the memory of the song that they are trying to imitate, and then adjust their vocalizations accordingly. This brain-behavior system is thought to be a model for how human infants learn to speak, so understanding it could prove crucial to future understanding and treatment of language disorders in children. In both songbirds and humans, feedback of self-produced vocalizations is compared to memorized vocal sounds and progressively refined to achieve a correct imitation. “Every neurodevelopmental disorder you can think of – including Tourette syndrome, autism, and Rett syndrome – entails in some way a breakdown in auditory processing and vocal communication. Understanding mechanisms of vocal learning at a cellular level is a huge step toward being able to someday address the biological issues behind the behavioral issues,” said Sarah Bottjer, senior author of an article on the research that appears in the Sept. 4 issue of the Journal of Neuroscience. Bottjer collaborated with lead author Jennifer Achiro, a graduate student at USC, to examine the activity of neurons in songbirds brains using electrodes to record the activity of individual neurons. In the basal ganglia – a complex system of neurons in the brain responsible for, among other things, procedural learning – Bottjer and Achiro were able to isolate two different types of neurons in young songbirds: ones that were activated only when the birds heard themselves singing, and others that were activated only when the birds heard the songs of adult birds that they were trying to imitate. The two sets of neurons allow the songbirds to recognize both their current behavior and a goal behavior that they would like to achieve.

— Compiled by Robert Kimball, MDD Staff Writer [email protected]

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