Mosie Baby gets FDA nod for at-home intravaginal insemination kit

By NS Medical Staff Writer

08 Dec 23

The over-the-counter Mosie Baby Kit is an at-home insemination kit designed for people who cannot conceive with intercourse…

RegulationApprovals

FDA classifies BD’s recall of Alaris infusion pumps as Class 1

By NS Medical Staff Writer

04 Dec 23

The pumps, which include BD Alaris Syringe Module, BD Alaris PCU, and Alaris PCA Module, are being recalled…

RegulationRecalls

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

AWAK Technologies Announces FDA Breakthrough Device Designation for their Artificial Intelligence Enabled Kidney Disease Prediction Tool

By NS Medical Staff Writer

28 Nov 23

The KDPP model helps to assess the risk of kidney disease progression and initiation of renal replacement therapy…

RegulationCertifications

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

FDA classifies B. Braun Medical’s recall of pump system as Class 1

By NS Medical Staff Writer

20 Nov 23

The Infusomat Space Volumetric Infusion Pump System models are being recalled by the company due to defective occlusion…

RegulationRecalls

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

FDA grants breakthrough device status to Toku’s patented cardiovascular risk AI (CLAiR) platform

By NS Medical Staff Writer

03 Nov 23

The CLAiR platform, if cleared by the FDA, will be the first medical device in the US market…

RegulationRegulatory Policy