Medical Devices Today

St. Jude Issues Court Challenge To Executive’s Move Rival Medtronic

 

Medtronic Wins FDA Panel’s Narrow Recommendation For Approval

Siemens, GE, Royal Philips See Profits In Selling Imaging Devices To China

Covidien Of Ireland Completes Acquisition Of Somanetics Of U.S.

Hologic To Get September FDA Review For 3-D Mammography Device

Genzyme Reported A Buyout Target Of France’s Sanofi-Aventis

Boston Scientific Warns Doctors Of Defects In Three Defibrillator Models

St. Jude, Zimmer Weather Hospital-Equipment Cuts When Others Do Not

Zimmer Of U.S. Seeks Takeover Of China’s Beijing Montagne

GE, Others With Patient-Monitoring Devices Face Roadblock In Boeing

Cook Medical Recalls Tracheostomy Devices With Covidien Element

Health Care Reform: The Excise Tax Was Only the Beginning

Article preview from Medtech Insight - June, 2010

The excise tax has been the medical device industry's main concern about pending health care reform, but other changes are taking place that will alter the market and potentially have a greater impact on sales and profits than the 2.3% tax. Specifically, device manufacturers' customers are at the beginning of changes that will alter reimbursement from the CMS to reflect adherence to standards of "best medical practices" tied to quality patient outcomes.

European Cost Concerns May Impact Devices

Article preview from IN VIVO - July, 2010

Medical device makers may have more difficult time selling in Europe than they'd anticipated as concerns over the economy and costs take hold, according to one analysis.

TCT Medical Offers A New Model For Device Distribution In China

Article preview from Start Up - July, 2010

China has become especially enticing as an unpenetrated, gigantic health care market, especially since the government in 2009 signed into effect a health care reform bill promising $125 billion over a three-year period to modernize the infrastructure of health care and provide insurance coverage to hundreds of millions of people. Medical device companies look to China as an enormous and rapidly growing market for medical disposables and equipment. However, the complex nature of the distribution infrastructure in China will make it difficult for companies to get a foothold. Headquartered in Beijing, TCT Medical Inc., which recently received $10 million in venture funding from Fidelity Asia Ventures and Fidelity Biosciences, its sister firm in the US, offers a potential solution for companies focused on women's health, and a model for the future.

CDRH Strategic Plan Calls For Database To Identify 'Compliance Targets'

Article preview from "The Silver Sheet" - July, 2010

FDA's device center wants to create a database to help officials and staff pinpoint "compliance targets" and develop detailed manufacturer risk profiles.

FDA, FCC Agree To Streamline Regulation Of Wireless Health Devices

Article preview from "The Gray Sheet" - July 27, 2010

FDA and the Federal Communications Commission hope to make life easier for developers of wireless medical devices by improving the efficiency of their overlapping regulatory processes, according to an agreement announced by heads of the two agencies July 26.

'We Should Have Acted Sooner' On DTC Gene Tests, Shuren Tells Lawmakers

Article preview from "The Gray Sheet" - July 26, 2010

CDRH has been busy for the past two months in an effort to bring direct-to-consumer genetic test services into its regulatory fold, but Center Director Jeff Shuren acknowledged to a House subcommittee last week that the agency was slow to tackle the matter.

Device Firms Criticize FDA Proposals To Share More Pre-Market Intel

Article preview from "The Gray Sheet" -July 26, 2010

Device and drug makers say FDA's draft proposals for publicly releasing more information on product applications would cripple the industry without providing much benefit to patients.

Philips, Zoll Battle Escalates As Zoll Files Patent Countersuit

 

Abbott Gets FDA Warning Letter Over Blood-Sugar Monitors

Boston Scientific Quarterly Report Shows Defib Problem Survival

J&J Draws On Other Device Sales To Overcome Defibrillator Problems

BD To Build Distribution Center, Create 190 Jobs In North Carolina

C.R. Bard, Covidien Class-Action Suits Could Be Merged In West Virginia

GE, Nihon Defibrillator Marketers Hit By Ordered Replacement Of 24,000

Biomet To Buy Cytosol Blood Products Maker For Undisclosed Amount

Bayer, Duramed IUDs Subject Of Physician Import Scandal

Boston Scientific Board Duo Sells Millions Of Shares As Value Declines

Medtronic CEO Got 6 Percent Compensation Increase In FY 2010

J&J, Covidien May Set Trend With Buys Of Neurovascular Firms

Boston Sci, Medtronic, Baxter, Stryker Rely On European Device Sales

Baxter Gets FDA Advice On Returning Infusion Pumps To Market

MDMA is hosting its annual Medical Technology Executive Forum

 

September 17^th in Palo Alto, CA. This must-attend forum will bring together more than 100 CEOs and senior executives to discuss critical issues affecting product commercialization. Speakers will discuss managing these key elements as a company plans for the successful launch of new products and technologies. Learn more:  http://www.medicaldevices.org/node/726