The U.S. Defense Dept. awarded $195.8 million worth of contracts to 3 medical device firms.
U.S. Defense Dept. awards $196M in contracts to medical device companies
Report: Smith & Nephew chairman Buchanan to step down | Personnel Moves
Cardiosonic closes 1st-in-human renal denervation trial, launches 2nd study
Cardiosonic Ltd. said it’s completed a 1st-in-human trial of its Tivus renal denervation device and has launched a 2nd trial.
The Tel Aviv-based medical device company is developing the Tivus device to treat high blood pressure using renal denervation. Unlike other renal denervation technologies that use radiofrequency energy to ablate the nerve lining the renal arteries, the Tivus device uses ultrasound waves.
Biolase, Auris in co-development deal for eye surgery robot
PLC Systems lands Japanese OK for RenalGuard trial
PLC Systems (OTC:PLCSF) won approval from the Japanese Ministry of Health, Labor & Welfare for a clinical trial of its RenalGuard device.
Shutdown ends, FDA user fees begin
The FDA can begin collecting user fees from medical device companies for fiscal 2014 now that the federal shutdown is over.
The watchdog agency announced new rates for the fees in August, but couldn’t begin collecting them when the fiscal year began Oct. 1 because of the shutdown that began that day.
Another recall for HeartSine Technologies
HeartSine Technologies issued a voluntary recall of some defibrillators models because of a defect that could lead to death.
The Belfast, U.K.-based medical device company said some of its older PDU 400 personal defibrillators were pulled because of a self-test defect that allows them to appear to be ready for use, despite having insufficient battery power.
Noble Biomaterials reups with KCI
Noble Biomaterials, a bacterial management company, said it renewed its partnership with KCI Manufacturing, an affiliate of Kinetic Concepts Inc., for its V.A.C. GranuFoam silver dressing.
Insulet appoints 1st medical director | Personnel Moves
Insulet (NSDQ:PODD) said it named Dr. Howard Zisser, the former clinical director of the Sansum Diabetes Research Institute, as its 1st medical director.
Considered a leader in diabetes research, Zisser will be involved with a variety of clinical research projects and serve as a medical liaison between Insulet and government leaders, the FDA, and healthcare organizations, Bedford, Mass.-based Insulet said.
FDA OKs clinical trial for Neuros Medical’s pain implant
Neuros Medical Inc. said it received an investigational device exemption from the FDA to run a clinical trial of its Altrius implantable generator to treat chronic pain in amputees.
The Altius device, consisting of an electrode and a generator, uses Neuros Medical’s patented electrical nerve block technology to deliver high-frequency stimulation to the peripheral nervous system to block chronic pain.
DePuy Synthes Spine, Brainlab expand collaboration
Johnson & Johnson (NYSE:JNJ) subsidiary DePuy Synthes Spine said it’s expanding its collaboration with Brainlab on surgical navigation and imaging devices, in addition to co-marketing Brainlab’s Airo Mobile Intraoperative CT.
