Cortical Dynamics secures US FDA 510(k) approval for BARM system version 1

By NS Medical Staff Writer

04 Sep 23

BARM technology is a next-generation certified class II personalised depth of anaesthesia monitoring device for usage in the…

RegulationApprovals

Femasys secures license to sell its medical devices in Canada

By NS Medical Staff Writer

01 Sep 23

The Medical Device Establishment License (MDEL), issued by Health Canada’s Regulatory Operations and Enforcement Branch (ROEB), allows Femasys…

RegulationApprovals

BionicM Earns FDA Registration and Class II Exempt Device Listing for Bio Leg; Its New Motor-Robotic Prosthetic Knee

By NS Medical Staff Writer

31 Aug 23

This registration marks a significant milestone in the company's commitment to deliver its robotic prosthetic knee to the…

RegulationApprovals

FDA clears BioProtect Balloon for rectal protection during prostate cancer radiation therapy

By NS Medical Staff Writer

29 Aug 23

The new generation spacer is designed to offer a defined, enclosed distance to minimise radiation exposure to the…

RegulationApprovals

Medtronic secures CE mark for Inceptiv SCS for chronic pain treatment

By NS Medical Staff Writer

28 Aug 23

Inceptiv has a closed-loop function that detects each person's own biological signals and modifies stimulation as necessary from…

RegulationApprovals

New Kerecis Medical-Fish-Skin Product Gets Quick Approval from Medicare Administrative Contractors

By NS Medical Staff Writer

28 Aug 23

More than 40% of the Medicare population now enjoys coverage for Kerecis Shield

RegulationApprovals

Aquedeon Medical Receives FDA IDE Approval for the Duett Vascular Graft System

By NS Medical Staff Writer

24 Aug 23

The study will be initiated in the second half of 2023, enrolling up to 20 patients at up…

RegulationApprovals

Wenzel Spine’s primaLOK SP gets FDA clearance for expanded indications

By NS Medical Staff Writer

23 Aug 23

Available commercially in the US, the primaLOK SP system combines advanced engineering with patient-focused design with the intent…

RegulationApprovals

Nevro unveils HFX Connect in Europe, gets expanded CE mark for HFX SCS system

By NS Medical Staff Writer

11 Aug 23

The HFX spinal cord stimulation (SCS) system from US-based Nevro has received the CE mark for painful diabetic…

RegulationCertifications

Theranica gets expanded CE mark indication for Nerivio in migraine

By NS Medical Staff Writer

10 Aug 23

Nerivio is a self-administered migraine bioband controlled by a smartphone app to relieve migraine pain and associated symptoms…

RegulationCertifications