Thoratec to go head-to-head with Abiomed’s Impella
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.
CardiAQ Valve wins FDA nod for mitral valve trial
CardiAQ Valve Technologies today said it won a nod from the FDA for an early feasibility trial of its 2nd-generation transcatheter mitral valve implant.
Australian PE shop acquires Simplify Medical
Simplify Medical said it was recently acquired by Australian private equity shop M.H. Carnegie for an undisclosed amount, as it gears up for a U.S. clinical trial of its MRI-safe artifical cervical disc.
FDA reports success in expediting approval process
The FDA’s Center for Devices & Radiological Health last week reported significant progress in speeding up the U.S. regulatory approval process for medical devices.
BiO2 Medical wins FDA nod for pivotal trial of Angel IVC catheter
BiO2 said it won an FDA nod for a pivotal trial of its Angel catheter and vena cava filter in the prevention of pulmonary embolism.
The 182-patient trial is a single-arm safety & efficacy study of the Angel device in patients at high risk for developing pulmonary embolism who can’t take standard drug therapies, according to a press release.
ImThera to begin U.S. testing of sleep apnea device
ImThera Medical said the FDA approved its investigational device exemption application to initiate a clinical study for its Aura6000 System for obstructive sleep apnea.
FDA OKs new AtriCure afib trial
Aethlon to provide Hemopurifier to treat Ebola in U.S.
Gynesonics wins FDA nod for VizAblate pilot trial
Gynesonics said it won an FDA investigational device exemption for its VizAblate system with an outpatient option for treating symptomatic uterine fibroids.
Sequent launches U.S. clinical trial of brain aneurysm device
Medtech company Sequent Medical enrolled the 1st 4 patients in a new U.S. clinical trial aimed at winning FDA approval for its Web aneurysm protection implant.
The Web implant is made of a Nitinol mesh that is delivered in a "stent-like" manner and deployed into the pouch formed by an aneurysm in order to prevent blood from flowing in. The device already has approve in the European Union.
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