Miach Orthopaedics, Inc., tells us its the BEAR® Implant is now commercially available in select U.S. cities. BEAR is designed … continue reading “BEAR® ACL Implant Launches in U.S.”
Products
vMAP™ Arrhythmia Hot Spot Detection System FDA Cleared
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”
3D LifePrints Medical 3D Printing Service for USA
Advanced 3D technology will enable host institutions to enjoy the benefits of having an ‘in-house’ virtual and 3D printed facility. … continue reading “3D LifePrints Medical 3D Printing Service for USA”
NovoSorb® BTM Synthetic Wound Matrix Launches at MEDICA
PolyNovo UK Ltd officially launch its NovoSorb® BTM synthetic dermal scaffold at MEDICA 2021 in November. Background Surgical and traumatic … continue reading “NovoSorb® BTM Synthetic Wound Matrix Launches at MEDICA”
Armstrong Medical to Launch AquaVENT® VT Heated Ventilator Circuits at MEDICA 2021
As the world battles a global respiratory disease, Armstrong Medical will be launching its new AquaVENT® VT heated ventilator breathing circuits … continue reading “Armstrong Medical to Launch AquaVENT® VT Heated Ventilator Circuits at MEDICA 2021”
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®”
Intersect ENT Launches VenSure Balloon Sinus Dilation and Cube Navigation System
Ear, nose and throat (ENT) specialist company Intersect ENT®, Inc., has announced the U.S. nationwide commercial availability of the VenSure™ … continue reading “Intersect ENT Launches VenSure Balloon Sinus Dilation and Cube Navigation System”
First-Ever Pivotal Trial of Synthetic Restorative Pulmonary Heart Valve
Based in Eindhoven, Netherlands, Xeltis is a clinical-stage developer of advanced polymer-based restorative cardiovascular devices. The company has now announced … continue reading “First-Ever Pivotal Trial of Synthetic Restorative Pulmonary Heart Valve”
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™”
Fourth FDA Breakthrough Device Award for Sirolimus DEB
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”
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”