The FDA has awarded MedAlliance breakthrough status for its SELUTION SLR™ sustained limus release Drug Eluting Balloon (DEB) catheter, in … continue reading “Fourth FDA Breakthrough Device Award for Sirolimus DEB”
Products
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”
Q‑Flow™ 2021 Targets Perfect Surgical Site Illumination
Surgical light technologist Merivaara has revealed its new improved Q-Flow™ 2021 offering. The system has been reformed in key features … continue reading “Q‑Flow™ 2021 Targets Perfect Surgical Site Illumination”
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
MedShape Launches DynaNail Mini® for Medial Column Fusion
Additional size offerings expands company’s portfolio of limb salvage surgical solutions. Background MedShape, Inc., the industry leader in orthopedic devices … continue reading “MedShape Launches DynaNail Mini® for Medial Column Fusion”
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.
Carpediem™ First Cardio-Renal Pediatric Dialysis Launch
Medtronic plc has announced the U.S. commercial launch of the Carpediem™ Cardio-Renal Pediatric Dialysis Emergency Machine, the first and only … continue reading “Carpediem™ First Cardio-Renal Pediatric Dialysis Launch”
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”
U.S. Launch for Boston Scientific SpaceOAR Vue™ Hydrogel
Next-generation Hydrogel spacer offers enhanced visibility via CT Scan to optimize treatment planning for patients undergoing radiation for prostate cancer. … continue reading “U.S. Launch for Boston Scientific SpaceOAR Vue™ Hydrogel”
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”