Virtual Incision announced today that it received investigational device exemption (IDE) from the FDA for its MIRA platform. MIRA, which stands for miniaturized in vivo robotic assistant, is touted by Virtual Incision as a first-of-its-kind miniaturized surgical platform, according to a news release. Receiving IDE allows Virtual Incision to initiate a clinical study of MIRA […]
Investigational Device Exemption (IDE)
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 Technologies today said it won a nod from the FDA for an early feasibility trial of its 2nd-generation transcatheter mitral valve implant.
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.
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 Medical said the FDA approved its investigational device exemption application to initiate a clinical study for its Aura6000 System for obstructive sleep apnea.
Gynesonics said it won an FDA investigational device exemption for its VizAblate system with an outpatient option for treating symptomatic uterine fibroids.