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

Virtual Incision receives FDA IDE supplement for MIRA platform

By NS Medical Staff Writer

20 Apr 22

FDA’s IDE supplement was based on the publication of positive interim clinical trial data on the safety profile…

Patient Care DevicesRegulationApprovals

Pear Therapeutics receives safer technologies program (STeP) designation from FDA for product candidate to treat acute and chronic pain

By NS Medical Staff Writer

14 Apr 22

Pear-010 is a PDT candidate intended to provide a neurobehavioral intervention to patients 18 and older with acute…

RegulationApprovalsDevices

TRUVIC announces 510(k) clearance for Prodigy Thrombectomy System

By NS Medical Staff Writer

12 Apr 22

First regulatory milestone as part of a strategy to advance patient care

RegulationApprovals

Arterys receives its eighth FDA clearance powered with AI and releases its next-generation Cardio AI application

By NS Medical Staff Writer

11 Apr 22

Receives eighth FDA clearance, releases its next-generation Cardio AI application

RegulationApprovals