Medical Devices Today

Congress, FDA Commissioner Question Device Pre-Market Review Process

Full article reprinted from "The Gray Sheet" - June 22, 2009

House Energy and Commerce Health Subcommittee Chair Frank Pallone said legislation is needed to restrict the types of devices cleared through FDA's 510(k) process. 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...

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...

The Digital Pathology Revolution: Breaking the Glass Ceiling

Article preview reprinted from Start-Up - May, 2009

Among diagnostic specialties, anatomic pathology is the last holdout against the digital revolution. Pathologists still detect disease by looking at tissue samples on a glass slide through a microscope, just as they have done for a hundred years. But in the last couple of years, start-up companies have begun to break the bondage of pathologists to slides. Their solution: platforms for digitizing slides so they can be accessed through computer networks by clinicians anywhere in the world. Two start-ups, Aperio and BioImagene, have led the way and now all the big imaging manufacturers, the microscope companies and biomarker developers want in. Read more...

Vnus Buy Latest Big Win for 2004 Device IPO Class

Article preview reprinted from Start-Up - May, 2009

The medical device industry broke the IPO ice in 2004, sending 17 companies onto the US public markets. How have they fared?

Covidien Set to Compete in Vascular Business

Article preview reprinted from IN VIVO -  May, 2009  

Covidien, following the acquisition of Vnus Medical Technologies and Bacchus Vascular, is establishing a global business unit focused on vascular surgery. Find out more...

Aesthetics Market: Fillers May Offer Bright Spot in Tough Times

Article preview reprinted Medtech Insight - May, 2009 

Signs point to a suppressed market for all aesthetics products for at least the remainder of 2009, but there's some evidence that dermal fillers have escaped the worst effects of the economic downturn. The American Society of Plastic Surgeons reports that while there was a 5% decrease in facelifts in 2008, the use of hyaluronic acid fillers was up by 6%, although dermal filler sales started to take a hit in the final quarter of the year. Find out more...

Sorin Restructured: Interview with Andre-Michel Ballester

Article preview reprinted from IN VIVO -  April, 2009  

Sorin, as a whole, has historically been known as a company more focused on R&D and technology development than on the commercial side of the business. Despite being among the market leaders in several cardiovascular product segments in both Europe and Asia, outside of cardiopulmonary devices Sorin is not a significant player in any other US product area. Sorin's CEO talks frankly to IN VIVO about why the company needed to reorganize to bring its sales and marketing efforts, particularly in the US, up to the level of its technology development. Find out more...