By Stewart Eisenhart, Emergo Group
New guidance from the US Food and Drug Administration spells out how medical device manufacturers and study sponsors should format standardized study data for electronic submission.
Medtronic landed a significant win with the announcement of an FDA win for its Resolute Integrity drug-eluting stent, the first device on the U.S. market cleared for patients with coronary artery disease as well as diabetes.
Diabetic patients make up about ⅓ of all those with CAD, and they represent a difficult-to-treat population.
Toshiba’s (TYO:6502) American medical products division won 510(k) clearance from the FDA for the latest iteration in its Aquilon line of CT scanners.
The Aquilon Prime is designed for healthcare facilities that need to perform a wide variety of advanced clinical examinations with reduced radiation exposure, according to a press release.
Medtronic Inc. (NYSE:MDT) landed FDA clearance for its DF4 high-voltage right ventricular lead for use with implantable cardiac rhythm management devices.
The DF4, which builds on Medtronic’s Sprint Quattro lead, aims to help simplify the implantation process with a redesigned port and by providing visual confirmation of the lead’s connection to the device.
Medtronic (NYSE:MDT) won 510(k) clearance from the FDA for the Aquamantys surgical sealer it acquired when it paid $480 million for Salient Surgical Technologies last year.
The FDA granted W.L. Gore & Associates the first U.S. clearance for using an endovascular graft to treat tears or ruptures in the aortic wall.
Gore’s Conformable TAG thoracic endoprosthesis was approved as a treatment for a transection or tear in the aortic wall, an injury typically the result of a car accident, crushing of the chest or a fall from a high place, according to an FDA release.
Smith & Nephew (NYSE:SNN) won a nod from the FDA for its Pico negative-pressure wound therapy system.
The British orthopedics giant’s wound care division said the FDA cleared the device for use in the home and in hospitals. It’s already on the market in Europe, Canada and Australia, according to a press release.
AtriCure (NSDQ:ATRC) shares got a modest bump today after revealing pre-market approval from the FDA for its Synergy radiofrequency ablation system for atrial fibrillation.
ATRC shares were up 2.1% to $10.86 as of about 1 p.m. today.
MASSDEVICE ON CALL —The Medical Device Patient Safety Act, introduced this week in the Senate, calls for increased safety measures for device approval from the FDA.
The bill, introduced by Sens. Chuck Grassley (R-Iowa), Herb Kohl (D-Wis.) and Richard Blumenthal (D-Conn.), would beef up the FDA’s safety regulations, allowing the federal watchdog agency to conduct safety studies of devices after they’ve been approved and to grant conditional approvals contingent on further trials.
Intuitive Surgical (NSDQ:ISRG) won 510(k) clearance from the FDA for its da Vinci surgical robot to be used in laparoscopic cholecystectomy – or gall bladder surgery.
The clearance for Sunnyvale, Calif.-based Intuitive covers single-site instrumentation for the da Vinci Si model, which will allow surgeons with the device to perform single-incision cholecystectomies, according to a press release.
Covidien (NYSE:COV) landed 510(k) clearance for its SpiderFX system to treat severely calcified lesions in the lower extremities.
The Mansfield, Mass.-based med-tech titan’s system has been on the European market since 2005 and is currently the only embolic protection device indicated for use in the lower extremities in the U.S.