Medical Devices Today

J&J Gets Panel Date Seeking First A-Fib Ablation Catheter Indication

Full article reprinted from "The Gray Sheet" - October 20, 2008

Johnson & Johnson's chances of becoming the first firm to market an ablation device in the U.S. labeled for treating atrial fibrillation will be clearer next month, when the company is scheduled to present PMA supplement data to an FDA advisory panel.

Obama Wants Comparative Effectiveness Institute; Is NICE A Good Model?

Full article reprinted from "The Gray Sheet" - October 20, 2008

Democratic presidential candidate Sen. Barack Obama has proposed a comparative effectiveness institute as part of his health care reform plan, but an independent analysis by the Lewin Group suggests that many physicians may not adopt the practices recommended by such a body.

Watch this Space: Medtech in the Middle East

Article preview reprinted from Start-Up - September 2008

With all the frenzy of investing, partnering, and joint-venturing in emerging markets like China and India, where can medtech investors still get in on the ground floor?

Big Tent for Stent Trial Is All About Predictability of Results

Article preview from IN VIVO Blog - October 17, 2008

Find out why a clinical trial collaboration among drug companies and drug-eluting stent companies looks to put to rest the late-stent thrombosis debate and kick start the DES market  -- but will it work, or will drug-eluding stents continue to be the Vioxx of the device industry?

FDA Will Give States Access To Its Recall Enterprise System By End Of FY ’09

Full article reprinted from "The Gray Sheet" - October 13, 2008

Find out when health and agriculture departments in all 50 states will have rapid access to FDA's Recall Enterprise System, that allows them a potentially greater role in product recall actions, the agency says.

AF Ablation: The Pulse of Innovation

Article preview reprinted Medtech Insight - September 2008

Find out how the atrial fibrillation market has attracted the attention of a large number of established and emerging cardiovascular device companies over the past several years, all hoping to cash in on the huge demand for a simple, safe, and effective therapy that can permanently cure this common, and often debilitating, heart arrhythmia.

WaveTec Prepares for a New Wave in Refractive Surgery

Article preview reprinted from Start-Up - September 2008

Refractive lens exchange is a mega opportunity in ophthalmology with the potential to serve the large patient populations with presbyopia and astigmatism. The category has been slow to take off, however, because current technology doesn't allow clinicians to meet, consistently and with confidence, the high expectations of new refractive surgery customers who are paying out of pocket for the benefit of great vision, at all distances. WaveTec has an enabling technology for a wide range of refractive surgeries to help clinicians and the many manufacturers of implantable intraocular lenses deliver on the promise of better vision.

Clinical Edge: Recent Advances in Research and Clinical Trials

Article preview reprinted Medtech Insight - September 2008

Brief summaries of recent advances in device research and clinical trials, including new evidence of the benefits of herniated disc surgery for older patients; the increase in the incidence of knee osteoarthritis; molecular breast imaging to detect breast cancer; the safety of endarterectomy for high-risk patients; and a new NIH grant program for innovative research.

Selected Start-Ups

Article preview reprinted from IN VIVO - September 2008

In Vivo briefly describes these recently founded companies: Clear Catheter Systems, Curant, DendriMed, Mirina, OcuSciences, and Zenobia Therapeutics.

FDA Prepares to Station Inspectors in China to Scrutinize Exports to the U.S

Featured Webinar from PharmAsia News - October 2008

Are your Chinese manufacturing facilities ready for heightened FDA inspections? What about the facilities of your outsourced Chinese suppliers? Join our exclusive Webinar on October 15 to hear from the FDA on how to prepare for inspections in China. To register or learn more, please click here.