Medical Devices Today

Medtronic To Lay Off Up To 1,800 Employees As Profits Drop

Cook Group Co-Founder Blasts Conflict-of-Interest Policies

Respironics Recalls Monitors For Detecting Apnea Episodes In Infants

Baxter Buys 40 Percent Stake In Sigma Infusion-Pump Maker

Medtronic Advises Problems With Older Pacemakers

Medtronic Said To Be Healthier Than Investors Think

Johnson & Johnson Says Stent Tests Better Than Boston Scientific’s

Medtronic To Lay Off Up To 1,800 Employees As Profits Drop

Boston Scientific Markets Third-Generation Taxus Stent

Medicare Denies Coverage Of CT Colonography For Cancer Screening

Full article reprinted from "The Gray Sheet" - May 18, 2009

The hopes of imaging equipment and software makers, the American Cancer Society and radiologists were dashed with CMS' final decision not to cover computed tomography colonography for colorectal cancer screening. Find out more...

“Real-World” ICD Benefit Displayed In Boston Sci Latitude Network Data

Full article reprinted from "The Gray Sheet" - May 18, 2009

New "real-world" data affirming the long-term benefits of implantable cardioverter defibrillators for heart failure patients highlighted the late-breaking trial sessions of the Heart Rhythm Society's 2009 conference in Boston last week. Find out more...

Do-Over? FDA Orders Look-Back At Knee Device 510(k) Review Process

Full article reprinted from "The Gray Sheet" - May 18, 2009

In a sign of the intense scrutiny CDRH is facing under the new administration, FDA is taking the rare step of performing an internal review of its decision process for a recently 510(k)-cleared device. Find out more...

The Promise of Social Media and Web 2.0 for Life Science Companies

An exclusive Q&A with Coleen Klasmeier, Partner and Head of Sidley's FDA Regulatory Practice and former Staff Attorney/Special Assistant to the Chief Counsel of FDA.

 
WATCH THE VIDEO PREVIEW
DOWNLOAD THE FULL 5-PAGE Q&A TRANSCRIPT

When Coleen Klasmeier talks about social media and the potential of Web 2.0 to her life science clients, she is talking about more than Twitter or Facebook.

"What we're talking about are the unprecedented opportunities (and challenges) the Web presents the life science industry," said Coleen Klasmeier who heads Sidley's FDA Regulatory Practice in Washington DC. "Pharma, medtech and biotech companies are just now starting to dip their toes in the largely untested regulatory waters that the enriched online communities of doctors and patient groups have to offer these companies," she added.

Coleen Klasmeier shared her insights with Medical Devices Today about:

• How some forward thinking medical device and other biomedical companies are taking advantage of social media while others sit on the sidelines
• Some of the complex business, legal and regulatory implications of social media for the life science industry
• How prepared the FDA and other regulatory agencies are to handle the issues created by Web 2.0

  Click here to download the exclusive 5-page Q&A with Coleen Klasmeier

Boston Scientific-Sponsored Study Shows Long-Term Value Of ICDs

• Boston Scientific-Sponsored Study Shows Long-Term Value Of ICDs

• Medtronic’s New Heart Devices Shown Compatible With MRIs

• Covidien Gets Unanimous Support Of FDA Advisers For Sealant

• Biomet Settles Suits Against W. Va. Doctor Over EBI Bone Devices

• Medtronic Wires Should Be Subjected To Post-Market Study: Doctors

• ReGen Biologics Knee Device Faces FDA Review Of Earlier Approval 

Cataract and Refractive Surgery: Hoping For a Rebound

Article preview reprinted Medtech Insight - May, 2009 

April's annual meeting of the American Society of Cataract and Refractive Surgery took place against of the darkest market backdrops in memory. The mood at ASCRS was not all gloom and doom, however. Cataract and refractive surgery technology continues to advance and a number of new product were introduced at the meeting. Find out more...

Living With REMS: The New Regulatory Model Meets Commercial Reality

Article preview reprinted from IN VIVO -  April, 2009   

Harvey Katzen, MD, has a complaint. As a busy physician running a hematology and oncology practice in suburban Maryland, he's frustrated that two new drugs, both of which were recently approved to combat an unusual blood disorder called chronic ITP, require a lot of extra paperwork before a patient can begin treatment.

Endoscopic Procedures Nose Up in ENT Market

Article preview reprinted from Start-Up - April, 2009

Ear, nose and throat surgery is the oldest surgical specialty in the US, and until recently, its age was all too apparent. Find out why...

Stryker Gets Subpoenas, Warning Letter Over Clinical Trials

 

Headlines from TopDeviceCompanies.com 

• Covidien To Pay $440 Million For VNUS Medical Technologies
• Stryker Gets Subpoenas, Warning Letter Over Clinical Trials
• St. Jude’s New Cardiac Defibrillators Get FDA Approval
• Covidien Unit’s Spinal Surgery Sealant Wins FDA Staff Support
• Siemens, GE Lose Medicare Coverage Of CT Scan Colonoscopies
• Medtronic To Locate Diabetes Center, 1,400 Jobs In San Antonio
• Medtronic To Apply To Use CRTs In Less-Severe Heart Patients
• Medtronic Gets Support Of Columnist Testifying Against Device Suits
• Boston Scientific Gets EU Approval For Implanted Defibrillator Wires