Asensus Surgical Receives FDA 510(k) Clearance for Expansion of Machine Vision Capabilities

By NS Medical Staff Writer

03 Sep 21

The current features of the ISU enable machine vision-driven control of the camera for a surgeon by responding…

RegulationApprovals

Zimmer, Canary get FDA de novo authorisation for smart knee implant

By NS Medical Staff Writer

31 Aug 21

Persona IQ integrates Zimmer Biomet's Persona knee implant with Canary Medical's canturio te tibial extension sensor technology

RegulationApprovals

FDA approves MicroTransponder Vivistim Paired VNS System

By NS Medical Staff Writer

30 Aug 21

Vivistim is claimed to be the first-of-its-kind system to treat moderate to severe upper extremity motor deficits associated…

RegulationApprovals

FDA approves IHS’ Insignis subcutaneous needle sets

By NS Medical Staff Writer

27 Aug 21

The Insignis subcutaneous needle sets are used for the subcutaneous infusion of medications in the home, hospital, ambulatory,…

RegulationApprovals

FX Solutions Receives FDA 510k Clearance for Lateralized and Augmented Glenoid Baseplates

By NS Medical Staff Writer

27 Aug 21

FDA Clearance Launches Additional Glenoid Baseplate Options Available to the Market Through FX

RegulationApprovals

FDA approves Medtronic’s next-generation TAVR system

By NS Medical Staff Writer

25 Aug 21

The new TAVR system will help deliver improved precision and control across the procedure, as well as maintain…

RegulationApprovals

FDA approves Vivos’ mmRNA device to treat mild to moderate OSA

By NS Medical Staff Writer

24 Aug 21

The modified mandibular Repositioning Nighttime Appliance device, which is part of the Vivos system treatment, is a non-surgical,…

RegulationApprovals

Qure.ai gets FDA nod for Brain CT AI product

By NS Medical Staff Writer

20 Aug 21

The Brain CT quantification tool will allow clinicians to quickly and accurately evaluate the severity of injury in…

RegulationApprovals

Second U.S. FDA Breakthrough Device Designation Granted to CytoSorbents’ DrugSorb-ATR Antithrombotic Removal System

By NS Medical Staff Writer

13 Aug 21

FDA Breakthrough Designation Granted to CytoSorbents' DrugSorb-ATR for Removal of Apixaban and Rivaroxaban to Reduce the Risk of…

RegulationApprovals

FDA approves 3NT Medical’s single-use Peregrine sinus endoscope

By NS Medical Staff Writer

12 Aug 21

Peregrine is suitable for use alongside the traditional 0° rigid endoscope or as the main endoscope in the…

RegulationApprovals