Transit Scientific’s XO Cath microcatheter gets FDA nod for embolic agent delivery

By NS Medical Staff Writer

01 Dec 23

According to the company, the XO Cath microcatheter is designed to offer new levels of torque response, trackability,…

RegulationApprovals

Vivos gets FDA clearance for Vivos’ CARE appliances to treat obstructive sleep apnoea

By NS Medical Staff Writer

30 Nov 23

The company’s flagship Vivos DNA oral appliance, the Vivos mRNA oral appliance, and the Vivos mmRNA oral appliance…

RegulationApprovals

Baird Medical gets FDA marketing clearance for Microwave Ablation Systems

By NS Medical Staff Writer

22 Nov 23

The FDA clearance designates Baird Medical Devices’ MWA Systems and MWA Needles as regulatory Class II devices in…

RegulationApprovals

J&J’s Ethicon gets CE mark approval for ETHIZIA haemostatic sealing patch

By NS Medical Staff Writer

16 Nov 23

Made from synthetic polymer technology, ETHIZIA is an adjunctive haemostat solution designed to achieve sustained haemostasis in difficult…

RegulationApprovals

NeuroSigma Announces FDA 510(k) Submission for Second Generation Monarch eTNS System

By NS Medical Staff Writer

08 Nov 23

Compared to the first-generation Monarch eTNS System, Monarch 2.0 has a smaller form factor, streamlined user interface, and…

RegulationApprovals

SeaStar gets FDA approvable letter for use of SCD in paediatric patients

By NS Medical Staff Writer

31 Oct 23

The SCD is a patented, cell-directed, extracorporeal device intended to be used as an additional therapy to lessen…

RegulationApprovals

VUNO receives FDA nod for VUNO Med-DeepBrain quantification device

By NS Medical Staff Writer

24 Oct 23

VUNO Med-DeepBrain is designed to automate the existing manual process of detecting, labeling and quantifying segmentable brain structures…

RegulationApprovals

Insulet Announces FDA 510(k) Clearance of the Omnipod 5 App for iPhone

By NS Medical Staff Writer

24 Oct 23

The Omnipod Insulin Management System provides a unique alternative to traditional insulin delivery methods

RegulationApprovals

Spectral AI’s DeepView SnapShot Wound Imaging System, Achieves UKCA Mark and FDA Class 1 Medical Device Classification

By NS Medical Staff Writer

20 Oct 23

DeepView SnapShot devices shipped to UK burn centers for evaluation

RegulationApprovals

VySpine Announces FDA Clearances for VySpan, VyLam and VySpine Innovations

By NS Medical Staff Writer

18 Oct 23

Trio of Clearances Expands VySpine’s Growing Product Portfolio

RegulationApprovals