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. GI Dynamics looks to next year for 2nd bite at FDA apple for EndoBarrier
GI Dynamics is hoping to make another run at FDA approval for its flagship EndoBarrier treatment for obesity and diabetes after its 1st try failed last year.
In a presentation accompanying the release of its 2nd-quarter numbers, the Lexington, Mass.-based medical device company said it’s busy repairing its relationship with the FDA and plans to finalize a bid for another investigational device exemption during the 1st half of 2017; GI Dynamics said it hopes to begin enrollment in the IDE trial by the end of June 2017. Read more
4. Spectranetics releases final 1-year results for Stellarex drug-coated balloon
Spectranetics today released the final 1-year results from the Illumenate EU RCT study comparing treatment with its Stellarex drug-coated balloon to percutaneous transluminal angioplasty, touting a 24% higher rate of primary patency with the DCB.
One-year results from the 328-patient trial were presented at the Amputation Prevention Symposium in Chicago this week. Read more
3. Avinger prices $30m follow-on offering
Avinger today priced a follow-on offering worth $30 million, saying it plans to dip into the cash if it needs to cover penalties for missed revenue covenants this year.
Redwood City, Calif.-based Avinger said it plans to float nearly 8.6 million shares at $3.50 apiece, plus a possible 1.3-million-share underwriters over-allotment that could bring in another $4.5 million. The offering is slated to close August 16, Avinger said. The company makes devices to treat peripheral vascular disease. Read more
2. Medtronic launches MiniMed 630G in U.S.
Medtronic announced the U.S. launch of the MiniMed 630G insulin management system it developed to work with a blood glucose meter made by Ascensia Diabetes Care.
The MiniMed 630G uses Medtronic’s SmartGuard software and a continuous glucose monitor to warn patients when glucose levels reach a preset low and to cease insulin delivery if the user doesn’t respond to the alarm, the Fridley, Minn.-based company said. Medtronic debuted the SmartGuard tech when it won pre-market approval for the MiniMed 530G system (the company has also reportedly filed for pre-market approval from the FDA for its MiniMed 670G “artificial pancreas”). Read more
1. Covidien spinout Mallinckrodt to acquire Stratatech
Mallinckrodt plc said today that it agreed to acquire Stratatech and its StrataGraft artificial skin graft technology for an undisclosed amount.
Mallinckrodt, the pharmaceuticals business spun out of Covidien in 2013, said the deal also includes Stratatech’s development program for genetically enhanced skin. The acquisition is expected to close before the end of the year, the Dublin-based company said. Read more
The post MassDevice.com +5 | The top 5 medtech stories for August 11, 2016 appeared first on MassDevice.
from MassDevice http://ift.tt/2bkA2GL
Cap comentari:
Publica un comentari a l'entrada