Artio Medical gets FDA approval for Solus Gold Embolization Device

By NS Medical Staff Writer

23 Mar 22

Solus Gold Embolization Device can be used to stop or slow down blood flow in the peripheral vasculature

RegulationApprovals

Orthofix secures FDA nod for TrueLok EVO Ring Fixation system

By NS Medical Staff Writer

17 Mar 22

The system is said to be the first circular fixator in the market designed for complex limb reconstruction…

RegulationApprovalsOrthopedic

Guardant Health gets regulatory approval in Japan for Guardant360 CDx

By NS Medical Staff Writer

15 Mar 22

A liquid biopsy test, Guardant360 CDx analyses circulating tumour DNA (ctDNA) from the blood samples of patients with…

RegulationApprovalsDiagnostic Devices

Cionic secures FDA approval for Neural Sleeve

By NS Medical Staff Writer

09 Mar 22

Neural Sleeve is an algorithm-powered bionic, leg-worn, lightweight garment designed to help people with mobility issues

RegulationApprovals

Health Canada approves bioLytical’s iStatis Covid-19 antigen test

By NS Medical Staff Writer

08 Mar 22

The approval will enable bioLytical Laboratories to sell iStatis Covid-19 antigen test across Canada for professional use in…

DevicesRegulationApprovals

Mawi gets CE mark for non-invasive sample collection devices

By NS Medical Staff Writer

07 Mar 22

The iSWAB non-invasive collection devices were also approved by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA)

RegulationApprovals

FDA approves Biobot Surgical’s new robotic-assisted transperineal needle-guidance system

By NS Medical Staff Writer

07 Mar 22

Urologists can use the new iSR'obot Mona Lisa 2.0 system to plan and position a single needle or…

RegulationApprovals

Gleamer’s BoneView AI software gets FDA clearance

By NS Medical Staff Writer

04 Mar 22

Approved as a CADe/CADx (computer-assisted detection and diagnosis) device, the BoneView AI software enables to diagnose fractures and…

RegulationApprovals

AltPep’s SOBA-AD test for Alzheimer’s disease secures FDA breakthrough status

By NS Medical Staff Writer

02 Mar 22

SOBA-AD is a simple blood test that has the ability to detect AD early before the symptoms arise

ApprovalsRegulationDiagnostic Devices

Viz.ai gets FDA nod for AI-based algorithm to detect cerebral aneurysms

By NS Medical Staff Writer

25 Feb 22

The new AI-based algorithm, dubbed Viz Aneurysm, is said to be the first of its kind population health…

RegulationApprovals