SeaStar gets FDA approvable letter for use of SCD in paediatric patients

By NS Medical Staff Writer

31 Oct 23

The SCD is a patented, cell-directed, extracorporeal device intended to be used as an additional therapy to lessen…

RegulationApprovals

Cordance Medical’s NeuroAccess Receives FDA Breakthrough Device Designation for Liquid Biopsy in Brain Tumors

By NS Medical Staff Writer

27 Oct 23

Transforming the Landscape of Neuro-Oncology Diagnostics Through Non-Invasive Blood-Brain Barrier Opening

RegulationCertifications

RF Medical Completed the Transition to European Medical Device Regulations (MDR) for Class IIb Medical Devices

By NS Medical Staff Writer

25 Oct 23

The MDR certificate encompasses all of RF Medical's product portfolios previously compliant with the MDD

RegulationCertifications

VUNO receives FDA nod for VUNO Med-DeepBrain quantification device

By NS Medical Staff Writer

24 Oct 23

VUNO Med-DeepBrain is designed to automate the existing manual process of detecting, labeling and quantifying segmentable brain structures…

RegulationApprovals

Insulet Announces FDA 510(k) Clearance of the Omnipod 5 App for iPhone

By NS Medical Staff Writer

24 Oct 23

The Omnipod Insulin Management System provides a unique alternative to traditional insulin delivery methods

RegulationApprovals

Spectral AI’s DeepView SnapShot Wound Imaging System, Achieves UKCA Mark and FDA Class 1 Medical Device Classification

By NS Medical Staff Writer

20 Oct 23

DeepView SnapShot devices shipped to UK burn centers for evaluation

RegulationApprovals

FDA Grants SeaStar Medical’s Selective Cytopheretic Device Breakthrough Device Designation for Hepatorenal Syndrome

By NS Medical Staff Writer

19 Oct 23

This is the third Breakthrough Device Designation granted by the FDA to SeaStar Medical for the SCD device,…

RegulationCertifications

VySpine Announces FDA Clearances for VySpan, VyLam and VySpine Innovations

By NS Medical Staff Writer

18 Oct 23

Trio of Clearances Expands VySpine’s Growing Product Portfolio

RegulationApprovals

Invitae’s Common Hereditary Cancers Panel Receives FDA Market Authorization

By NS Medical Staff Writer

04 Oct 23

First-of-its-kind authorization provides potential marketing differentiation and opportunities for largest testing category

RegulationApprovals

Anumana’s ECG-AI LEF device gets FDA nod for low ejection fraction detection

By NS Medical Staff Writer

03 Oct 23

Developed in partnership with Mayo Clinic, ECG-AI LEF is an artificial intelligence-driven software-as-a-medical device to screen LEF using…

RegulationApprovals