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”
Products
CE Mark for Ortho’s COVID-19 IgG Antibody Test
A few weeks ago we reported that Ortho Clinical Diagnostics had seen its COVID-19 total antibody test CE marked. Now … continue reading “CE Mark for Ortho’s COVID-19 IgG Antibody Test”
Now Ortho’s COVID Antibody Test Gains CE Mark
Ortho Clinical Diagnostics, a global leader of in vitro diagnostics has announced that its COVID-19 total antibody test received CE … continue reading “Now Ortho’s COVID Antibody Test Gains CE Mark”
FDA Emergency Use Authorization for Ortho’s COVID-19 Total Antibody Test
The U.S. FDA has granted Emergency Use Authorization to Ortho Clinical Diagnostics’ total antibody assay for COVID-19 – the VITROS® … continue reading “FDA Emergency Use Authorization for Ortho’s COVID-19 Total Antibody Test”
Revivent TC Less Invasive Ventricular Enhancement Therapy CE Mark Extended to 2024
BioVentrix, Inc., developer of the first transcatheter device for left ventricular remodeling after a heart attack, has announced the extension … continue reading “Revivent TC Less Invasive Ventricular Enhancement Therapy CE Mark Extended to 2024”
CE Mark for “World First” Single-Use Duodenoscope, EXALT Model D
Boston Scientific Corporation has gained the CE Mark and initiated a limited market release of the EXALT™ Model D Single-Use (disposable) … continue reading “CE Mark for “World First” Single-Use Duodenoscope, EXALT Model D”
UK Innovations Launched at Arab Health 2020
The Association of British HealthTech Industries (ABHI) has revealed some of what it describes as ground-breaking digital health technologies, services … continue reading “UK Innovations Launched at Arab Health 2020”
Newly Cleared Cranial Robotic System Sees First Paediatric Deployment
Phoenix Children’s Hospital, is the first health system in the U.S. to receive and deploy the newly FDA-cleared Medtronic Stealth … continue reading “Newly Cleared Cranial Robotic System Sees First Paediatric Deployment”
Seers Medical Launches Clinnova Couches at MEDICA
Seers Medical, the leading UK manufacturer of treatment, examination and rehabilitation furniture has been showing off its groundbreaking range of … continue reading “Seers Medical Launches Clinnova Couches at MEDICA”
XACT Robotic System Cleared by FDA for Percutaneous Interventional Procedures
XACT Robotics™ Ltd. tells us that its first robotic system has been cleared to market in the U.S. for use during … continue reading “XACT Robotic System Cleared by FDA for Percutaneous Interventional Procedures”
CE Mark for Boston Scientific’s VERCISE™ Neural Navigator 3 Programming Software
Boston Scientific Corporation has announced the CE Mark approval of its Vercise™ Neural Navigator 3 directional Deep Brain Stimulation (DBS) programming … continue reading “CE Mark for Boston Scientific’s VERCISE™ Neural Navigator 3 Programming Software”
Limited Release of BioCardia AVANCE™ Steerable CV Catheter Introducer
Following its recent FDA clearance, BioCardia, Inc. has confirmed the U.S. commercial availability of the AVANCE™ Bi-Directional Steerable Introducer Sheath for introducing … continue reading “Limited Release of BioCardia AVANCE™ Steerable CV Catheter Introducer”
Medtronic Submits InterStim™ Micro Neurostimulator and SureScan™ MRI Leads to FDA
Medtronic plc tells us it has filed a pre-market approval (PMA) supplement with the U.S. FDA for approval of its … continue reading “Medtronic Submits InterStim™ Micro Neurostimulator and SureScan™ MRI Leads to FDA”
Ethicon’s New Stapler Targets Anastomotic Leak Reduction
J & J company, Ethicon has announced the launch of the ECHELON CIRCULAR™ Powered Stapler which preclinical studies say reduce … continue reading “Ethicon’s New Stapler Targets Anastomotic Leak Reduction”
FDA Breakthrough Device Designation for SoniVie’s TIVUS Pulmonary Arterial Hypertension System
Pulmonary Arterial Hypertension (PAH) treatment specialist SoniVie, has been granted Breakthrough Device Designation from the U.S. FDA for the Therapeutic … continue reading “FDA Breakthrough Device Designation for SoniVie’s TIVUS Pulmonary Arterial Hypertension System”
CE Mark for Orchestra BioMed BackBeat Cardiac Neuromodulation Therapy™ for Hypertension
Orchestra BioMed™, Inc., tells us it has received CE Mark approval for its Moderato® implantable pulse generator system that delivers BackBeat … continue reading “CE Mark for Orchestra BioMed BackBeat Cardiac Neuromodulation Therapy™ for Hypertension”