MedTech News

Roche wins FDA approval for first molecular malaria blood donor screening test
The company is pitching the test as a way to improve the safety and availability of blood.

Endostart receives FDA clearance for Endorail product to optimize colonoscopy procedural outcomes
Endorail is a magnetic balloon solution that optimises colonoscopy procedural outcomes.

Blood, Sweat, and Water: New Paper Analytical Devices Easily Track Health and Environment
Novel inexpensive, shelf-stable, easy-to-use tests bring lab-level precision to the home and field

Synaptive Medical Receives FDA 510(k) Clearance for Near-Infrared Fluorescence Visualization, Expanding Application of Existing Robotic Exoscope
Near-Infrared fluorescence now available on Modus X robotic exoscope, complementing system’s existing advanced fluorescence capabilities

Medtronic announces FDA approval of newest-generation Evolut TAVR system for treatment of symptomatic severe aortic stenosis
The Evolut™ FX+ TAVR system leverages market-leading valve performance with addition of larger windows to facilitate coronary access

SyntheticMR receives FDA 510(k) clearance for their next Generation Solution SyMRI 3D
“We are thrilled to receive 510(k) clearance for SyMRI 3D,” says Ulrik Harrysson, CEO at SyntheticMR AB”

GC Aesthetics launches FixNip implant to ‘revolutionize’ breast reconstruction for women
FixNip NRI is a nipple implant for women who have undergone breast reconstruction surgery

Calyxo Announces FDA Clearance for New, Redesigned CVAC System
New Solution for Kidney Stone Treatment Already Used to Treat More than 50 Patients