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”
Approval/Clearance
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”
FDA Breakthrough Device Designation for Cala Trio™ Therapy to Treat Action Tremors in Parkinson’s Disease
The U.S. FDA has granted Breakthrough Device Designation to Cala Trio™ for the treatment of action tremors in the hands … continue reading “FDA Breakthrough Device Designation for Cala Trio™ Therapy to Treat Action Tremors in Parkinson’s Disease”
CE Mark for Medovate SAFIRA® Single-Handed Regional Anaesthesia Device
Anaesthesia and airway management pioneer in critical care and surgery, Medovate, has received CE Mark Approval for its game-changing medical … continue reading “CE Mark for Medovate SAFIRA® Single-Handed Regional Anaesthesia Device”
FDA Approval for Biosense Webster THERMOCOOL SMARTTOUCH® SF Ablation Catheter for Persistent Atrial Fibrillation
Johnson & Johnson Medical Devices Companies have announced the U.S. FDA approval of Biosense Webster, Inc.’s THERMOCOOL SMARTTOUCH® SF Ablation … continue reading “FDA Approval for Biosense Webster THERMOCOOL SMARTTOUCH® SF Ablation Catheter for Persistent Atrial Fibrillation”
Two New FDA-Approved Bladder and Bowel Control Therapies
Medtronic plc, has received approval from the US FDA for its InterStim™ Micro neurostimulator and InterStim™ SureScan™ MRI leads. Background … continue reading “Two New FDA-Approved Bladder and Bowel Control Therapies”
CMS Approval for SINUVA® Sinus Implant
Intersect ENT®, Inc., a company dedicated to transforming care for patients with ear, nose and throat conditions, has gained Centers … continue reading “CMS Approval for SINUVA® Sinus Implant”