Regulatory News

1. Medtronic's InterStim Micro Neurostimulator, InterStim SureScan MRI Leads Gain CE Mark 1/13/2020

   Medtronic plc (NYSE:MDT) today announced it has received CE Mark for its InterStim™ Micro neurostimulator and InterStim™ SureScan™ MRI leads — clearing the technologies for commercial sale and clinical use in Europe.

2. FDA Clears Medtronic's Stealth Autoguide System For Cranial Procedures 12/18/2019

   Medtronic plc (NYSE:MDT) announced that the U.S. Food and Drug Administration (FDA) recently cleared the Stealth Autoguide™ system, the first cranial robotic platform that integrates with Medtronic’s enabling technology portfolio to create an end-to-end procedural solution.

3. Medtronic Submits InterStim Micro Neurostimulator And SureScan MRI Leads For FDA Approval 10/7/2019

   Medtronic plc (NYSE:MDT) today announced it has filed a pre-market approval (PMA) supplement with the United States Food and Drug Administration (FDA) for approval of its InterStim™ Micro neurostimulator and also its InterStim™ SureScan™ MRI leads.

4. FDA Grants Breakthrough Designation To SoniVie's TIVUS System To Treat Pulmonary Arterial Hypertension 9/6/2019

   SoniVie, an Israeli company developing a novel system for the treatment of PAH, today announced that it has been granted Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for the Therapeutic Intra-Vascular Ultrasound (TIVUS) System in patients with PAH.

5. Orchestra BioMed's Cardiac Neuromodulation Therapy Device For Hypertension Earns CE Mark 9/4/2019

   Orchestra BioMed™, Inc., (“Orchestra BioMed” or the “Company”), a biomedical innovation company providing high-impact solutions for large unmet needs in procedure-based medicine, announced today that it has received CE Mark approval for its Moderato® implantable pulse generator system that delivers BackBeat Cardiac Neuromodulation Therapy™ (CNT) for treatment of hypertension while also providing standard pacemaker functions.

6. FDA Clears Dominion Aesthetic Technologies' Non-Contact Body Sculpting 6/25/2019

   Dominion Aesthetic Technologies, Inc. recently announced that it has received FDA clearance for its body contouring product, eon FR, which is a non-contact medical device that reduces fat.

7. FDA Clears Itamar Medical's Fully Disposable Home Sleep Apnea Test 6/6/2019

   Itamar Medical Ltd. (Nasdaq:ITMR) (TASE:ITMR), a company that develops, manufactures and markets non-invasive diagnostic medical devices for sleep apnea with a focus on the cardiology market, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration for WatchPAT One, the latest innovation of its WatchPAT technology and the first and only fully disposable Home Sleep Apnea Test (HSAT).

8. FDA Approves BD's First Venous Stent To Treat Iliofemoral Venous Occlusive Disease 3/14/2019

   BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced the U.S. Food and Drug Administration has granted premarket approval for the Venovo™ venous stent, the first stent indicated to treat iliofemoral venous occlusive disease, which is obstructed or narrowed blood flow specific to the iliac and femoral veins located near the groin.

9. CurvaFix Receives FDA 510(k) Clearance For CurvaFix Rodscrew 3/5/2019

   CurvaFix, Inc., a developer of medical devices to repair bone fractures in orthopedic trauma patients, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the CurvaFix® Intramedullary Rodscrew. CurvaFix’s patented solution has the potential to improve outcomes and enable a less invasive approach in pelvic trauma surgery.

10. FDA Clears Medtronic's Accurian RF System For Nerve Tissue Ablation 2/27/2019

    Medtronic plc recently announced U.S. Food and Drug Administration (FDA) 510(k) clearance of the Accurian(TM) RF ablation platform, which conducts radio frequency (RF) ablation of nerve tissues.