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.
The U.S. Food and Drug Administration has further formalized its ongoing review of the controversial Essure permanent birth control implant from Bayer.
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.
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 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.
Orthopedics specialist Smith & Nephew is removing particular hip implant sizes and related components from the market after data from the U.K.'s National Institute for Health and Care Excellence found that smaller sizes of the Birmingham Hip Resurfacing System had revision rates that exceed its benchmarked expectations. It's also advising against any use of the system in women. But despite the data, it's not advising that patients with the now-contraindicated implant have proactive revisions.
Calhoun Vision has been around a long, long time for a startup. But now it's got a massive infusion of $69 million that's following on the heels of the addition of a new, market-focused CEO from Bausch + Lomb to help catapult it into commercialization.
Vital Access has secured a $10 million credit facility from Deerfield Management to expand marketing of its FDA-cleared implant to make it easier to access the vascular system of end-stage renal disease patients for hemodialysis. The cash is also intended to invest in additional vascular access products that might stem from the company's platform.
SI-Bone gained FDA clearance for its iFuse Implant System in November 2008 and a CE mark in November 2010. Now, it's brought in a new CFO and a $21 million cash infusion to help ramp up sales and, perhaps, to ready it for an IPO. The news comes after the startup revealed positive 6-month data and its surgical category gained a reimbursement code earlier this year.
Outside of surgery, physicians can do very little to treat severe rotator cuff tears. Israeli company OrthoSpace is aiming to offer a new treatment option. It's raised an $8 million venture round led by Healthpoint Capital that will finance a pivotal, U.S. trial for the company's biodegradable balloon system InSpace.