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”
Products
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”
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”
Xfree® Extraction-Free Direct RT-PCR Test: FDA Emergency Use Authorization Submission
Molecular diagnostics solutions company, BioGX has announced the FDA Emergency Use Authorization (EUA) submission of an extraction-free, direct sample addition … continue reading “Xfree® Extraction-Free Direct RT-PCR Test: FDA Emergency Use Authorization Submission”