Vektor Medical, Inc. has gained U.S. FDA 510(k) clearance for its novel computational ECG mapping system, vMap™. The non-invasive technology … continue reading “vMAP™ Arrhythmia Hot Spot Detection System FDA Cleared”
Approval/Clearance
FDA Clearance for 3NT Peregrine™ Sinus Endoscope
ENT Endoscope specialist, 3NT Medical has gained FDA clearance for its Peregrine™ Drivable ENT Scope. Peregrine is designed to provide … continue reading “FDA Clearance for 3NT Peregrine™ Sinus Endoscope”
FDA Breakthrough Device Status for Hancock Jaffe VenoValve®
Cardiac and Vascular device developer Hancock Jaffe Laboratories, Inc., tells us that the U.S. FDA has granted Breakthrough Device Designation status to … continue reading “FDA Breakthrough Device Status for Hancock Jaffe VenoValve®”
Pain Relief Boost with Spinal Cord Stimulator Approval
Pain relief using implantable neurostimulation has come on a lot in recent times. For evidence, try searching our pages. Now … continue reading “Pain Relief Boost with Spinal Cord Stimulator Approval”
U.S. FDA Approves Pipeline™ Flex Embolization Device with Shield Technology™
Medtronic plc has received U.S. FDA approval for Pipeline™ Flex Embolization Device with Shield Technology™. Background An estimated 500,000 people throughout the … continue reading “U.S. FDA Approves Pipeline™ Flex Embolization Device with Shield Technology™”
FDA Approves Expanded Labeling of Medtronic MRI Leads
Medtronic plc says it has received approval from the U.S. FDA for expanded MRI labeling of its InterStim™ II and InterStim™ … continue reading “FDA Approves Expanded Labeling of Medtronic MRI Leads”
FDA Clears Vetex ReVene Thrombectomy Catheter
Vetex Medical Ltd. tells us that the U.S. FDA 510(k) has cleared its the ReVene® Thrombectomy Catheter. Vetex expects to make the … continue reading “FDA Clears Vetex ReVene Thrombectomy Catheter”
CE Mark for Robotic Cancer Detection Probe
Now with CE mark approval, Lightpoint Medical’s SENSEI® becomes the first robotic gamma probe to be commercially available to European … continue reading “CE Mark for Robotic Cancer Detection Probe”
CMS Code for Intersect ENT PROPEL® Sinus Implant
Ear, nose and throat (ENT) specialist Intersect ENT®, Inc. tells us about a new Centers for Medicare and Medicaid Services (CMS) … continue reading “CMS Code for Intersect ENT PROPEL® Sinus Implant”
De Novo FDA Nod for Miach ACL Healing Implant
Miach Orthopaedics, Inc., has announced that the U.S. FDA has granted the company’s De Novo Request for the Bridge-Enhanced® ACL Repair (BEAR®) Implant.
FDA Clearances Enhance Mazor™ Robotic Guidance System
The U.S. FDA has cleared the use of navigated interbody and Midas Rex™ high speed drills with the Mazor™ Robotic Guidance System earlier than originally anticipated
FDA OKs ReCor Paradise™ Ultrasound Renal Denervation
ReCor Medical’s Paradise™ Ultrasound Renal Denervation System has received Breakthrough Device Designation from the U.S. FDA for the treatment of patients with uncontrolled hypertension who are inadequately responsive to anti-hypertensive medications.
CE Mark for ORTHO Optix™ Reader
CE mark for ORTHO Optix™ Reader means lower volume transfusion labs in Europe will now be able to offer results … continue reading “CE Mark for ORTHO Optix™ Reader”
Penumbra’s Indigo® Cleared for Pulmonary Embolism
Penumbra, Inc. has announced U.S. FDA 510(k) clearance for expanded indication of the Indigo® Aspiration System, Lightning™ 12. Background Pulmonary embolism, … continue reading “Penumbra’s Indigo® Cleared for Pulmonary Embolism”
FDA Says Yes to 130 Per Hour SARS-CoV-2 Test
in vitro diagnostics company, Ortho Clinical Diagnostics has announced that the U.S. FDA has accepted its Emergency Use Notification (EUN) … continue reading “FDA Says Yes to 130 Per Hour SARS-CoV-2 Test”
Chronic Disease Management “Chatbot” Offers a Vision of Future
Nori Health launches CE-certified iPhone app to guide chronic bowel patients. Background Globally more than half of adults are believed … continue reading “Chronic Disease Management “Chatbot” Offers a Vision of Future”