Say hello to MassDevice +3, a bite-sized view of the top three medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 3 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.

 

3. FDA approves Gore’s Viabahn for peripheral stent repair

W.L. Gore & Assoc. said the FDA granted pre-market approval for a new indication for its Viabahn endoprosthesis, to treat failed bare-metal stents in the peripheral vasculature.

The Viabahn device 1st won an FDA nod in 2005 for treating femoral artery lesions. A string of expanded indications has followed, including the most recent approval for treating in-stent restenosis in the superficial femoral artery, Gore said. Read more

2. Appeals court vacates FDA’s rescission of ReGen’s MenaFlex implant

ReGen Biologics won a round in its long battle with the FDA over its MenaFlex knee implant last week when a federal appeals court vacated the watchdog agency’s move to rescind clearance for the collagen mesh implant and ordered “further proceedings” for the device.

The Hackensack, N.J.-based company declared bankruptcy in 2011, a year after the FDA’s Center for Devices & Radiological Health pulled its 510(k) clearance for the Menaflex device. ReGen sued in the U.S. District Court for the District of Columbia to overturn the rescission, calling it “arbitrary and capricious, an abuse of discretion, not in accordance with law, and in excess of statutory jurisdiction, authority and limitations.” Read more

1. Diabetes: Patients hack glucose monitors

More and more patients are hacking into their glucose monitors to add functionality, with medical device companies lagging behind as they work their own improvements through the FDA, according to the Wall Street Journal.

One example is NightScout, an open-source software program that hacks into a Dexcom Inc. monitor and uploads its data to the Internet. The information can then be relayed to smart phones and devices, allowing diabetic patients (and, in many cases, their parents) to monitor their blood sugar levels wherever they are. Read more