NeuroMetrix’s Quell neuromodulator gets FDA approval to treat fibromyalgia

By NS Medical Staff Writer

20 May 22

The Quell neuromodulation device is said to be the first non-pharmacological treatment for fibromyalgia which received FDA Breakthrough…

RegulationApprovals

Teleflex secures Health Canada approval for MANTA device

By NS Medical Staff Writer

19 May 22

The approval will enable the firm to increase the availability of the MANTA device globally, and it gives…

DevicesRegulationApprovals

US FDA classifies recall of Avanos Medical’s Cortrak* 2 EAS as Class I

By NS Medical Staff Writer

17 May 22

The Cortrak* 2 EAS device has been designed to help health care professionals to place the medical feeding…

RegulationRecalls

BELKIN Vision’s Eagle receives CE Mark under MDR

By NS Medical Staff Writer

17 May 22

BELKIN's sight-saving technology could revolutionize first-line glaucoma care for the more than 100 million people who have glaucoma…

RegulationCertifications

Abbott secures FDA approval for test to detect four STIs simultaneously

By NS Medical Staff Writer

05 May 22

The multiplex test is based on Abbott’s advanced molecular PCR platform, the Alinity m system, for fast results…

DevicesRegulationApprovals

FDA grants Breakthrough Device status for X-Therma’s XT-ViVo and TimeSeal solutions

By NS Medical Staff Writer

04 May 22

The FDA’s Breakthrough Device status will enable the firm to speed up the development, evaluation, and review procedures…

RegulationApprovals

Health Canada approves use of Dolphin Vagal Nerve Stimulator

By NS Medical Staff Writer

04 May 22

The device is intended to treat symptoms like shortness of breath, cough, fatigue, joint and muscle pain, headaches,…

DevicesRegulationApprovals

Nanox subsidiary receives FDA approval for HealthOST device

By NS Medical Staff Writer

29 Apr 22

HealthOST is an AI software for spinal analysis of vertebral compression fractures and low bone density often associated…

RegulationApprovalsDevices

CoNextions TR Tendon Repair System receives FDA clearance

By NS Medical Staff Writer

26 Apr 22

Expected to launch in May 2022, the novel system addresses traumatic tendon lacerations in the hand, wrist, and…

RegulationApprovals

Fresenius Medical gets FDA 510(k) clearance for VersiPD Cycler System

By NS Medical Staff Writer

22 Apr 22

The portable automated peritoneal dialysis (APD) system is claimed to be the lightest, smallest and quietest dialysis cycler…

RegulationApprovals