Reach Neuro gets FDA breakthrough status for Avantis platform

By NS Medical Staff Writer

11 Apr 23

Avantis platform uses small electrical impulses and delivers them to the spinal cord to help restore arm, shoulder,…

RegulationCertificationsMotors & Motion Control

Micronoma Receives FDA Breakthrough Device Designation for OncobiotaLUNG, A Novel Liquid Biopsy Assay for Lung Carcinoma Detection

By NS Medical Staff Writer

11 Jan 23

The OncobiotaLUNG assay is the first blood microbiome-driven liquid biopsy with proven effectiveness, including identifying cancer in its…

DevicesCertificationsDiagnostic Devices

Opticyte gets FDA breakthrough designation for Cell O2 Patient Monitor

By NS Medical Staff Writer

10 Jan 23

The device uses the firm’s proprietary machine-learning technology to noninvasively diagnose organ dysfunction caused by inadequate cellular oxygenation…

Patient Care DevicesCertificationsPatient Care Monitoring

PRAPELA RECEIVES FDA’S BREAKTHROUGH DEVICE DESIGNATION TO INVESTIGATE THE USE OF STIMULATION TO TREAT APNEA OF PREMATURITY

By NS Medical Staff Writer

09 Jan 23

Prapela's stimulation pad could become available sooner as a new treatment option for preterm newborns experiencing apnea

RegulationCertificationsSurgical and Supplies

Allotrope Medical announces FDA Safer Technologies Program (STeP) designation for their surgical device StimSite

By NS Medical Staff Writer

08 Nov 22

For the past year, StimSite has been used by surgeons to help locate and identify ureters through electrical…

Patient Care DevicesCertificationsSurgical and Supplies

OptraSCAN secures CE-IVDR for OS-Ultra digital pathology system

By NS Medical Staff Writer

29 Jul 22

The OS Ultra scanners deliver high-resolution images that can be analysed further with the help of OptraSCAN's artificial…

DevicesCertificationsDiagnostic Devices

UK to tighten regulation of medical devices for patient safety

By NS Medical Staff Writer

27 Jun 22

The reforms will cover medical devices like hearing aids, x-ray machines and insulin pumps; new technologies such as…

RegulationCertifications

BELKIN Vision’s Eagle receives CE Mark under MDR

By NS Medical Staff Writer

17 May 22

BELKIN's sight-saving technology could revolutionize first-line glaucoma care for the more than 100 million people who have glaucoma…

RegulationCertifications

Optellum wins CE mark for AI-based early lung cancer detection tool

By NS Medical Staff Writer

31 Mar 22

The AI-based tool is capable of identifying and tracking at-risk patients with suspicious lung nodules for the detection…

DevicesRegulationCertifications

BSI issues first UKCA mark under new medical devices legislation

By NS Medical Staff Writer

29 Jan 21

Theatre instrument sets are the first to secure the new UK product marking

RegulationCertifications