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Investigational Device Exemption (IDE)

Virtual Incision receives FDA IDE for miniaturized robot-assisted surgery platform

October 27, 2020 By Sean Whooley

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 […]

Filed Under: Food & Drug Administration (FDA), Regulatory/Compliance, Robotics, Surgical Tagged With: FDA, Investigational Device Exemption (IDE), Virtual Incision Corp.

Thoratec to go head-to-head with Abiomed’s Impella

May 26, 2015 By Brad Perriello Leave a Comment

Thoratec to go head-to-head with Abiomed's Impella

Filed Under: News Well, Structural Heart Tagged With: Abiomed, Clinical Trials, Investigational Device Exemption (IDE), Thoratec Corp.

FDA OKs trial for StimGuard’s bladder implant

May 11, 2015 By Fink Densford Leave a Comment

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.

Filed Under: Neuromodulation/Neurostimulation, News Well, Urology Tagged With: Clinical Trials, Investigational Device Exemption (IDE), StimGuard, Stimwave

CardiAQ Valve wins FDA nod for mitral valve trial

April 10, 2015 By Brad Perriello Leave a Comment

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.

Filed Under: Food & Drug Administration (FDA), News Well, Regulatory/Compliance, Replacement Heart Valves Tagged With: CardiAQ Valve Technologies, Clinical Trials, Investigational Device Exemption (IDE)

Australian PE shop acquires Simplify Medical

March 23, 2015 By Brad Perriello Leave a Comment

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.

Filed Under: Mergers & Acquisitions, News Well, Orthopedics, Regulatory/Compliance, Spine Tagged With: Investigational Device Exemption (IDE), M.H. Carnegie, Simplify Medical, Venture Capital/Private Equity

FDA reports success in expediting approval process

January 29, 2015 By Val Kennedy Leave a Comment

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.

Filed Under: Food & Drug Administration (FDA), News Well, Pre-Market Approval (PMA), Regulatory/Compliance Tagged With: Investigational Device Exemption (IDE)

BiO2 Medical wins FDA nod for pivotal trial of Angel IVC catheter

January 16, 2015 By Brad Perriello Leave a Comment

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.

Filed Under: Food & Drug Administration (FDA), News Well, Vascular Tagged With: Angel Medical Systems Inc., Clinical Trials, Investigational Device Exemption (IDE)

ImThera to begin U.S. testing of sleep apnea device

November 13, 2014 By Val Kennedy Leave a Comment

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.

Filed Under: Food & Drug Administration (FDA), News Well Tagged With: ImThera Medical Inc., Investigational Device Exemption (IDE), Sleep Monitoring/Sleep Apnea

FDA OKs new AtriCure afib trial

November 3, 2014 By Brad Perriello Leave a Comment

FDA OKs new AtriCure afib trial

AtriCure (NSDQ:ATRC) said it won an investigational device exemption from the FDA for a 1st-of-its-kind clinical trial involving patients with non-paroxysmal atrial fibrillation.

Filed Under: Food & Drug Administration (FDA), News Well Tagged With: AtriCure Inc., Cardiac Rhythm Management, Clinical Trials, Investigational Device Exemption (IDE)

Aethlon to provide Hemopurifier to treat Ebola in U.S.

October 29, 2014 By Val Kennedy Leave a Comment

Aethlon to provide Hemopurifier to treat Ebola in U.S.

Filed Under: Food & Drug Administration (FDA), News Well Tagged With: Aethlon Medical Inc., Ebola, Investigational Device Exemption (IDE)

Gynesonics wins FDA nod for VizAblate pilot trial

October 23, 2014 By Alexander Soule Leave a Comment

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.

Filed Under: Food & Drug Administration (FDA), Gynecological, News Well Tagged With: Clinical Trials, Gynesonics, Investigational Device Exemption (IDE)

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