Latest Headlines

Latest Headlines

Abbott moves more into mitral valve med tech, to buy startup for $250M and options another

Abbott will buy two mitral valve replacement startups, moving it even further into med tech after a series of high-profile deals last year. It obviously sees the sector as a way for it to plan for long-term growth--since its innovative biopharma candidates went with AbbVie when the companies split in early 2013.

Edwards ups TAVR guidance on Sapien 3 launch, looks to expand indication in 2016

Edwards Lifesciences bumped up its transcatheter heart valve sales estimate for 2015 due to what it anticipates will be a strong U.S. launch for its third-generation TAVR device, Sapien 3. It was approved in June within a day of an FDA approval for a similar device from Medtronic, so the next quarter's earnings will start to tell the tale on how that U.S. next-gen TAVR competition will play out.

Implanting a titanium tube inside damaged bones improves procedure to ward off amputations

A titanium rod implanted inside a bone can improve limb-lengthening procedures that are used to prevent the need for limb amputation, a study in the journal  Clinical Orthopaedics and Related Research  co-published by Loyola University orthopedic surgeon Dr. Mitchell Bernstein found.

FDA approves the first implantable, above-the-knee prosthesis

The U.S. Food and Drug Administration has approved an option for patients who have trouble with the standard socket leg prosthetics that are typically used for those with above-the-knee amputation. The implantable prosthetic requires two surgeries, but it's intended to encourage prosthetic usage and to improve patient outcomes.

NSF spends almost $31M to develop dissolvable metal surgical implants

The National Science Foundation has coughed up almost $31 million since 2008 in an effort to develop what it has dubbed "smart implants" that address the underlying medical issue but then dissolve.

FDA gives nod to newest pelvic mesh product, despite ongoing safety issues

The U.S. Food and Drug Administration has signed off on the latest iteration of a pelvic mesh, despite the ongoing controversy around this type of device and a huge settlement from Medtronic for more than 11,000 vaginal mesh patients earlier this week.

FDA panel slated to weigh Bayer Essure safety after more than 5,000 complaints

The U.S. Food and Drug Administration has further formalized its ongoing review of the controversial Essure permanent birth control implant from Bayer.

Medtronic reports early pivotal data for tiny leadless pacemaker with U.S. launch slated in a year or so

Cardiac Rhythm & Heart Failure is one of Medtronic's faster growing businesses, driven in part by the launch of tiny subcutaneous heart monitor Reveal Linq. The medical device giant expects that the launch of supersmall leadless pacemaker Micra Transcatheter Pacing System could help it to keep that revenue growth momentum going.

Watchman study author says it's better than warfarin at preventing hemorrhagic stroke

A meta-analysis of the data surrounding Boston Scientific's recently approved stroke-preventing Watchman device concluded that it reduces risk of death from hemorrhagic stroke, cardiovascular death, and major non–procedural-related bleeding compared to patients on long-term use of the blood thinner warfarin.

Intarcia readies for FDA in 2016 as it reports detailed Phase III data for once-yearly diabetes implant

Intarcia expects to report Phase III data during the second half of 2015 for the remaining two of its four pivotal trials in its program for once-yearly exenatide implant ITCA 650. If all goes well, it plans to head to the FDA next year. This week, the company offered detailed results at the American Diabetes Association (ADA) conference in Boston from June 5-8 for its two Phase III trials that had already reported data in October 2014.