Say hello to MassDevice +7, a bite-sized view of the top seven med-tech stories of the week. This latest feature of MassDevice.com’s coverage highlights our seven biggest and most influential stories from the week’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.
If you read nothing else this weekend, make sure you’re still in the know with MassDevice +7.
7. Cordis issues “urgent” recall on Fire Star Rx balloon catheters
Johnson & Johnson subsidiary Cordis Corp. issues an "urgent product recall" on a certain lot of its Fire Star Rx PTCA dilation catheters over a potential for "slow deflation" or "no deflation."
6. Internal FDA disputes may affect regulatory outcomes for medical devices
The FDA’s Center for Devices & Radiological Health needs better conflict management procedures to guide device reviewers on scientific disputes that may affect regulatory decisions, according to a report from the Dept. of Health & Human Services’ Office of the Inspector General.
5. Ex-Stryker CEO MacMillan headed to Johnson & Johnson’s Synthes unit?
As the completion of the union between Synthes Inc. and Johnson & Johnson (NYSE:JNJ) draws near, there’s an awfully good executive sitting on the sidelines: former Stryker (NYSE:SYK) CEO Stephen MacMillan.
Read more
4. FDA panel backs Edwards’ Sapien heart valve for lower-risk patients
An FDA advisory panel almost unanimously recommends expanded indication to approve Edwards Lifesciences’ Sapien transcatheter aortic heart valve for lower-risk patients, despite concerns about possible biases in clinical trials.
3. Medtronic’s recalled Fidelis leads fracture after ICD swap, researchers say
Researchers tie fractures in Medtronic’s recalled defibrillator leads with implantable cardioverter defibrillator replacement procedures, warning that all post-swap patients may be at risk.
2. Ethicon warns on counterfeit surgical clips on the U.S. market
Johnson & Johnson subsidiary Ethicon Endo-Surgery discovers distribution of counterfeit LigaClip surgical closures in the U.S.
1. BSX’s Mahoney details outlook on up-and-coming businesses, including renal denervation and ICDs
Boston Scientific CEO Michael Mahoney details the med-tech titan’s 2012-2013 development and regulatory approval timelines for its up-and-coming business regions, including for its newly acquired Cameron Health subcutaneous implantable defibrillators and its bronchial thermoplasty business.
