Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.
Get this in your inbox everyday by subscribing to our newsletters.
5. Power morcellation rates plunged after FDA warnings
Use of electric power morcellation for hysterectomy procedures has significantly declined after the FDA warned against the use of such devices in 2014, according to a new study.
Data from the study was published this month in the Journal of the American Medical Association. Read more
4. Opko Health gets in on BioCardia after merger with Tiger X Medical
BioCardia said today that Opko Health agreed to pick up a “significant” stake in its business after a merger with Tiger X Medical.
The new company will keep the BioCardia name and the development program for its CardiAMP cell therapy for heart failure patient’s who’ve had a heart attack. Stem cells derived from the bone marrow of patients likely to respond to the therapy, as indicated by testing for BioCardia’s biomarker, are delivered at a high dose using the Helix catheter. Read more
3. Medtronic closes $1B HeartWare buyout
Medtronic said today that it’s closed the $1.1 billion acquisition of implantable cardiac pump maker HeartWare International.
The $58-per-share deal clears the field of the 2 major cardiac assist device makers, after Medtronic’s cross-town rival, St. Jude Medical, paid $3 billion for Thoratec in October 2015 (St. Jude is now being acquired by Abbott for $25 billion). HeartWare’s implantable left ventricular assist devices are designed for end-stage heart failure patients, either as a destination therapy until death or as a bridge to heart transplantation. Read more
2. Lombard Medical exits U.S. market, shares jump
Lombard Medical Technologies said yesterday that it’s bailing out of the U.S. market after an FDA decision requiring a 50-patient clinical study of its Intelliflex low-profile delivery system for the Aorfix stent graft.
Lombard said it eliminated its U.S. sales force and moved most of its commercial operations to its U.K. facility, significantly reducing its cash burn. Read more
1. FDA, medical device industry strike deal over user fees
The FDA and the medical device industry hammered out the principles for the user fees medtech companies pay to have the federal safety watchdog review their products.
The 4th iteration of the Medical Device User Fee & Modernization Act would allow the FDA to collect nearly $1 billion in user fees over 5 years, beginning in October 2017. The last MDUFMA bill, enacted in 2012, doubled user fees from $295 million over 5 years to $595 million, in exchange for performance goals set for the FDA. Read more
