Medical Devices Today

Device Makers To Supreme Court: Investors Don't Need Adverse Event Reports Without Statistical Backing

Article preview from "The Gray Sheet" - August 31, 2010

Could medical product firms have to file a disclosure with the Securities and Exchange Commission or issue a press release for every adverse event report?

Shuren's Center: FDA Device Chief Discusses Long Road To 510(k) Reform

Article preview from "The Gray Sheet" - August 30, 2010

FDA has put its proposals on the table for reforming the 510(k) pre-market clearance program, but the crucial activity will take place over the coming weeks as FDA fields comments and decides which initiatives will get the green light.

Venture HHS: Planned Gov't Fund For Emergency Products Elicits VC Caution

Article preview from "The Gray Sheet" - August 23, 2010

The Obama administration plans to ask Congress to authorize an independent strategic investment fund to provide financial support for small companies developing medical products that can be used to respond to bioterror attacks, pandemic flu outbreaks or other public health emergencies.

Medtronic Expands Ortho Biologics Presence With Osteotech Acquisition

Article preview from "The Gray Sheet" - August 18, 2010

Medtronic is shoring up its orthopedic biologics business through the acquisition of demineralized bone matrix marketer Osteotech for $123 million.

Medical Device User Fee Negotiations: Here We Go Again

Article preview from "The Gray Sheet" - August 16, 2010

FDA is holding a meeting Sept. 14 to start a public dialogue on the next reauthorization of medical device user fees, more than two years before Congress needs to renew the program.

Seeking New Options for Prostate Cancer

Article preview from Medtech Insight - August, 2010

Recent reports questioning the benefits of early prostate cancer diagnosis and treatment have raised an industry-wide debate that has been fueled by the limitations of prostate-specific antigen tests, currently the standard of care for early prostate cancer detection. While the industry searches to improve the use of PSA tests, urologists are asking, "are we over treating our patients?" That question was repeatedly voiced in a number of forums at the American Urological Association's 2010 Annual Meeting. As for a definitive answer to the question, it is a somewhat difficult task to get individual physicians to admit they are personally over treating patients; however, there is definitely a consensus-and a concern-that more patients than necessary are receiving treatments that put them at risk of serious side effects.

Industry Preps For Excise Tax Implementation While Repeal Effort Continues

Article preview from "The Gray Sheet" - August 11, 2010

The medical device excise tax is still several years from first collection and many in industry are focusing on repeal or revision of the measure, but some attorneys say companies should start seeking answers now from the federal government on how the tax will be implemented.

'Least Burdensome' Provisions Revisited In FDA Regulatory Science Report

Article preview from "The Gray Sheet" - August 9, 2010

FDA is seeking to rein in the device industry's interpretation of the "least burdensome" statutory provisions, which govern how much data regulators may ask for during pre-market reviews.

'Least Burdensome' Provisions Revisited In FDA Regulatory Science Report

Article preview from "The Gray Sheet" - August 9, 2010

FDA is seeking to rein in the device industry's interpretation of the "least burdensome" statutory provisions, which govern how much data regulators may ask for during pre-market reviews.

The Future of Laparoscopy: Single Incision, NOTES and Robots

Article preview from Start Up - July, 2010

The skill sets of laparoscopy, endoscopy, robotics and even interventional cardiology are all converging to create least invasive surgeries that take laparoscopy as a point of departure but change how surgeons access the abdominal cavity. Start-ups are innovating to supply the new surgical instruments.