Shockwave Medical is reporting positive 6-month results from study of its "lithoplasty" balloon catheter for treating peripheral artery disease, saying the device passed its efficacy and safety measures with flying colors.
Stealthy Atia Medical lands $5m Series B round
Medtronic’s Arctic Front Advance ST wins FDA approval
ImThera begins pivotal trial for Aura6000 sleep apnea implant
ImThera Medical said the 1st 2 U.S. patients in a clinical study of its Aura6000 sleep apnea therapy were successfully implanted with the device. The surgeries were performed by Dr. Sam Mickelson of Advanced Sleep Centers in Atlanta, Ga.
FDA OKs trial for StimGuard’s bladder implant
StimGuard said it won an investigational device exemption from the FDA for a clinical trial of its micro-size implantable device to treat overactive bladder syndrome. StimGuard said its system uses a small injectable microchip and an external transmitter and requires no invasive surgery to implant. The trial is slated to begin in summer 2015.
Clear Guide Medical inks Army deal
Clear Guide Medical signed a contract with the U.S. Army’s Institute of Surgical Research to test its Clear Guide One physician assistance device. The device will be installed at the USAIR headquarters in San Antonio, Texas, where Dr. Jose Salinas will be the primary investigator.