Medical Devices Today

Stroke Devices: Facing Challenges Head On

Article preview reprinted Medtech Insight - May, 2009 

The International Stroke Conference, held in San Diego in February 2009, presented several device-based therapies and approaches that could offer improved outcomes for patients that suffer an acute ischemic stroke. The technologies discussed included mechanical thrombectomy devices, laser treatments, and combined therapy using ultrasound, microspheres, and thrombolytic drugs. Read more... 

Health Care Reforms Target Medical Devices

Article preview reprinted from IN VIVO -  May, 2009 

Welcome to 2009. If you haven't been paying attention to the health care happenings in the nation's capital this year, you should be. The President and powerful members of Congress have put themselves on the line to remake the US health care system; whistleblowers within FDA's device review office are charging management with breaking the law; federal mandates for more transparency in doctor-manufacturer relationships have become the lesser of evils for many in industry; and one of the most significant device-specific US Supreme Court decisions in recent memory has become a vulnerable target of leading Democratic lawmakers. As Steve Ubl, president and CEO of AdvaMed, recently observed, "What happens over the next 25 weeks could affect the industry over the next 25 years." Read more...

Medtech Investing 2009: What's Changed?

Article preview reprinted from Start-Up - May, 2009

The medical device industry is undergoing a crisis of funding, but not of confidence, according to a panel of investors convened at Windhover's recent medtech conference, In3 West,. The conference panel sought to explore how the medical device investment community is operating in these troubled times, how they will invest going forward, and how they will support their companies if things don't improve. We were especially curious to know if the funding challenges that start-ups face are really due to the overall dire economy, or if that dark cloud merely masks changing fundamentals in the medical device industry that are making it more difficult for companies to find funding, gain FDA approval, and enjoy a healthy exit. Our panel weighs in on the matter. Read more...

Device Companies Urge Whistleblowers To Air Complaints In-House

Full article reprinted from "The Gray Sheet" - June 15, 2009

Device companies are trying to encourage employees to report suspected fraud internally rather than going straight to government authorities - with limited success to date. Read more...

Preliminary Decision By CMS Keeps NPWT Devices In One Code

Full article reprinted from "The Gray Sheet" - June 15, 2009

CMS is proposing to keep negative pressure wound therapy devices in one Healthcare Common Procedure Coding System code, in line with recommendations from the Agency for Healthcare Research and Quality. Read more...

Firms Must Draw Hard Line Between Royalty, Training Deals, Experts Say

Full article reprinted from "The Gray Sheet" - June 15, 2009

Companies need to be wary of blurring distinctions between payments made to physicians for product royalties and as compensation for training colleagues, compliance experts warn. Read more...

Synthes, Executives Charged With Promoting Unapproved Bone Filler Use

• Synthes, Executives Charged With Promoting Unapproved Bone Filler Use
• Medtronics, St. Jude, 3M, Others Buy Ideas From Small Minnetronix
• Alcon Buy Jeopardizes Novartis Plan For Separate Acquisition
• Medtronic, Others Count Key Congress Members As Shareholders
• Medtronic Admits Broader Financial Ties To Discredited Army Doctor
• J&J Spends $1.5 Million Lobbying Health-Care Issues In Three Months
• Zimmer To Trim More Than 4 Percent Of Global Staff

FDA Requirements for Device Software: Are You in Compliance?

Join our panel of industry leaders, including three top FDA attorneys, a former Medtronic software developer turned medical software consultant and the industry's leading expert on system validation and safety risk management to find out how even small medical device software problems can mean BIG REGULATORY TROUBLE for medical device manufacturers.

Don't Miss:
FDA Requirements for Device Software: Are You in Compliance?
A Windhover Webinar

Wednesday, July 22, 2009 at 2:00 pm EDT (90 minutes)
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Clinical Edge

Article preview reprinted Medtech Insight - May, 2009 

Brief summaries of recent advances in device research and clinical trials, including new research on laparoscopic gastrectomy for stomach cancer, stem cell therapy for damaged corneas, delayed-enhancement MRI for atrial fibrillation, and the role of metal debris in causing inflammation post-joint implants. Read more...

Changing Minds at the FDA

Article preview reprinted from IN VIVO -  May, 2009  

Visioncare's recent success in getting an FDA advisory panel to change a recommendation is a rare and noteworthy achievement. But the agency could prove to be an even more formidable barrier - and a potential catalyst for change - for the device sector going forward. Read more...