Medical Devices Today

St. Jude Unveils Plan To Launch Transcatheter Aortic Valve By 2012

Full article reprinted from "The Gray Sheet" - February 16, 2009

Find out how St. Jude Medical plans to begin clinical trials of a transcatheter aortic heart valve system by the end of 2010, with the goal of earning a CE mark for European marketing in mid-2012.

NeuroMetrix Settles Kickback Charges Related To Device Marketing

Full article reprinted from "The Gray Sheet" - February 16, 2009

Find out how NeuroMetrix will pay $3.7 million to the government and comply with a five-year corporate integrity agreement to settle allegations that it provided illegal kickbacks to physicians as part of a marketing program for its NC-stat neuropathy diagnostic system.

Updates on Vietnam’s Medical Device Market

A live webcast presented by Pacific Bridge Medical

February 26, 2009

11:00 AM EST – 12:30 PM EST

 

Vietnam is a growing medical device market, especially for manufacturing and sourcing as China gets more expensive. Increasingly open for more foreign trade, Vietnam is quickly becoming the next emerging market in Asia with many high-tech companies moving their facilities there. Make sure you know all the regulatory hurdles, medical device environment to capture the most of Vietnam’s cost-savings potential and market.

Aestus Therapeutics Inc.

Article preview reprinted from Start-Up - January, 2009

Find out how Aestus Therapeutics is using its bioinformatics platform to hunt down previously unsuspected associations between validated drug targets and neurological disease, to seek out compounds relevant to that target; ideally candidates that got as far as Phase II.

GI Dynamics: In Metabolic Disease a Device Might Trump Drugs

Article preview reprinted from IN VIVO - January 2009

A device start-up looks to succeed where drugs have failed: influencing multiple metabolic pathways to treat obesity and reverse type 2 diabetes.

Health Care Trends: Health Care's Economic Woes Continue

Article preview reprinted Medtech Insight - January 2009

Find out how the effects of the current financial crisis are becoming more apparent in the health care arena, where payors, providers, suppliers and everyone else involved in the industry re-evaluate their respective strategies.

FDA Approves J&J’s Navistar ThermoCool For Atrial Fibrillation Ablation

Full article reprinted from "The Gray Sheet" - February 09, 2009

PMA approval Feb. 6, Johnson & Johnson/Biosense Webster's NaviStar ThermoCool and EZ Steer ThermoCool Navigational became the first cardiac ablation catheters approved by FDA specifically for treatment of atrial fibrillation.

White House Health Official Supports Cost-Effectiveness Research

Full article reprinted from "The Gray Sheet" - February 09, 2009

Find out how Jeanne Lambrew, President Obama's top health policy expert, said comparative cost information on medical treatments could be a useful part of overall health care reform.

Parting Words: Larry Kessler Urges CDRH To Put Science Over Clinical Hopes

Full article reprinted from "The Gray Sheet" - February 09, 2009

Find out how for longtime FDA staffer Larry Kessler, now is a hard time to be leaving the agency.