Cerus Endovascular receives FDA breakthrough device designation for Contour Neurovascular System

By NS Medical Staff Writer

12 Feb 21

Indicated for the treatment of intracranial aneurysms, the Contour Neurovascular System™, composed of fine mesh braid, represents a…

RegulationApprovals

CardiacSense gets CE mark for medical grade watch

By NS Medical Staff Writer

11 Feb 21

The medical watch enables continuous measurement of heart rate and arrhythmias

RegulationApprovals

Roche gets FDA breakthrough device status for Elecsys GDF-15 assay

By NS Medical Staff Writer

09 Feb 21

The assay uses the sandwich test format for the detection of GDF-15 in human serum

RegulationApprovals

ShiraTronics receives FDA breakthrough device designation for chronic migraine neurostimulation

By NS Medical Staff Writer

09 Feb 21

The FDA Breakthrough Device Program is intended to help patients receive more timely access to breakthrough technologies that…

RegulationApprovals

FDA approves Signifier’s device for obstructive sleep apnea

By NS Medical Staff Writer

08 Feb 21

The eXciteOSA device delivers neuromuscular stimulation to the tongue to reduce snoring and mild sleep apnea

RegulationApprovals

B-Secur receives FDA regulatory clearance for HeartKey EKG/ECG technology

By NS Medical Staff Writer

08 Feb 21

B-Secur’s HeartKey is a suite of EKG/ECG algorithms that uniquely combine user identification, health and wellness to generate…

RegulationApprovals

FDA approves Precision Spine’s Dakota ACDF standalone system

By NS Medical Staff Writer

05 Feb 21

The system is designed for use in skeletally mature patients with degenerative disc disease of the cervical spine…

RegulationApprovals

FDA approves Pulse Biosciences’ CellFX system

By NS Medical Staff Writer

04 Feb 21

The CellFX system is approved for dermatologic procedures, which need ablation and resurfacing of the skin

RegulationApprovals

FDA grants EUA status to new Covid-19 antibody test

By NS Medical Staff Writer

04 Feb 21

The new Covid-19 antibody test has the ability to predict whether a patient will experience mild versus more…

RegulationApprovals

Inovytec gets FDA nod for Ventway Sparrow ventilators

By NS Medical Staff Writer

03 Feb 21

Ventway Sparrow ventilators help to offer both invasive and noninvasive ventilation for patients weighing above 5kg

RegulationApprovals