Neuromod wins CE Mark for tinnitus device
November 26, 2014 by Val Kennedy
Dublin-based Neuromod Devices said it won CE Mark approval in the European Union for its new multi-sensory device to treat tinnitus, also known as “ear-ringing.”
The product, mutebutton, is a handheld device that helps the brain distinguish between real and phantom noises through audio and tongue stimulation. Read more
Vascular Solutions wins FDA nod for Gel-Block embolization foam
November 25, 2014 by Mark Hollmer
Minnesota’s Vascular Solutions said it won 510(k) clearance from the FDA for a pre-cut gelatin foam used to treat abnormal blood vessels and some tumors. Marketing of the product is already underway, the company said.
The FDA OK’d Vascular Solutions’ Gel-Block 10x embolization pledgets for treating hypervascular tumors (growths that display a huge number of blood vessels) and arteriovenous malformations (snarled tangles of arteries and veins). Read more
Philips wins FDA clearance for IQon Spectral CT system
November 26, 2014 by Val Kennedy
Royal Philips said it won 510(k) clearance from the FDA for its IQon Spectral CT system for enhanced computed tomography imaging.
“Through the Spectral CT scan, clinicians can access the conventional grey-scale anatomical images, along with the spectral information within the same scan. As a result, Philips IQon Spectral CT enables real-time, retrospective data analysis, without disrupting a clinician’s workflow and takes the guesswork out of multi-energy acquisitions, making it easy to use and allowing for routine spectral use,” the Dutch company said in a press release. Read more
EU allows GI Dynamics EndoBarrier back on the market
December 1, 2014 by Mark Hollmer
European regulators cleared GI Dynamics to resume sales of its EndoBarrier weight loss device, now that the Massachusetts company resolved concerns over use guidelines and how it reports adverse events.
EndoBarrier is a plastic lining delivered endoscopically into the small intestine, designed to treat obesity and Type II diabetes by slowing the absorption of nutrients into the body. Read more
Diabetes: FDA approves Animas Vibe with DexCom's G4 Platinum CGM
December 1, 2014 by Brad Perriello
Animas said today that the FDA granted pre-market approval for the Animas Vibe insulin pump, featuring Dexcom’s continuous glucose monitoring sensor technology, in patients age 18 and older.
Johnson & Johnson’s Animas touted the Animas Vibe as the only system integrated with DexCom’s G4 Platinum CGM sensor, saying it provides diabetics with their most recent glucose readings (the system is designed to take a reading every 5 minutes). The Animas Vibe is also designed to report glucose highs, lows and rates of change so patients can fine-tune their insulin regimen, the company said. Read more