Orthofix announces FDA clearance of OrthoNext digital platform for JuniOrtho Plating System

By NS Medical Staff Writer

11 May 21

Developed specifically for use with the JuniOrtho Plating System, the OrthoNext digital platform software enables the surgeon to…

RegulationApprovals

EDGe Surgical receives CE mark for EDG Ortho 65mm electronic depth gauge

By NS Medical Staff Writer

11 May 21

Enables access to New EU markets and potential to work with larger manufacturers preparing for EU Medical Device…

RegulationApprovals

Perosphere Technologies gets CE mark for PoC Coagulometer system

By NS Medical Staff Writer

10 May 21

The PoC Coagulometer technology helps measure the intrinsic clotting time of fresh whole blood

RegulationApprovals

FDA approves Viome’s mRNA technology and AI platform to detect oral and throat cancers

By NS Medical Staff Writer

10 May 21

Viome's mRNA technology and AI platform powers its at-home Health Intelligence Test

RegulationApprovals

MY01 receives FDA clearance for MY01 Continuous Compartment Pressure Monitor as an aid in diagnosis of Compartment Syndrome

By NS Medical Staff Writer

07 May 21

The MY01 Continuous Compartmental Pressure Monitor is a sterile, single-use device

RegulationApprovals

EXINI gets CE mark for AI-based medical device software aPROMISE

By NS Medical Staff Writer

04 May 21

aPROMISE will help conduct quantitative assessment of prostate-specific membrane antigen PET/CT in oncology

RegulationApprovals

Medtronic gets CE mark for Evolut PRO+ TAVI system to treat severe aortic stenosis

By NS Medical Staff Writer

04 May 21

The new Evolut PRO+ TAVI system is launched in four-valve sizes with an external pericardial tissue wrap

RegulationApprovals

FDA approves MOLLI wire-free localisation technology for breast cancer surgery

By NS Medical Staff Writer

03 May 21

The technology enables radiologists to mark lesions rapidly and precisely

RegulationApprovals

Lumenis receives FDA approval for its IPL device to manage dry eye disease and launches OptiLight

By NS Medical Staff Writer

30 Apr 21

Subsequent to the FDA approval, Lumenis is launching OptiLight, a bright solution for dry eyes

RegulationApprovals

FDA approves AtriCure’s EPi-Sense system to treat persistent atrial fibrillation

By NS Medical Staff Writer

30 Apr 21

CONVERGE trial showed superiority in the hybrid AF therapy arm compared to endocardial catheter ablation alone

RegulationApprovals