Squid Healthcare Announces FDA 510(k) Submission for EyeMask MD

By NS Medical Staff Writer

23 Sep 21

The company’s FDA submission is supported by biocompatibility data as well as bench data in support of Over-The-Counter…

RegulationApprovals

FDA approves Paige Prostate AI-based software to detect prostate cancer

By NS Medical Staff Writer

22 Sep 21

Paige Prostate software has the potential to detect an area of interest on the prostate biopsy image with…

RegulationApprovals

FDA approves Abbott’s Portico with FlexNav TAVR system

By NS Medical Staff Writer

21 Sep 21

Portico, which is implanted using FlexNav TAVR system, is indicated for the treatment of people with symptomatic and…

RegulationApprovals

Masimo gets CE mark for single-patient-use rainbow SuperSensor

By NS Medical Staff Writer

14 Sep 21

The multi-purpose SuperSensor uses 12 LEDs to simultaneously provide 12 blood constituent parameters noninvasively and continuously

RegulationApprovals

Joimax Receives FDA Clearance to Market EndoLIF Delta-Cage and DoubleWedge-Cage in US

By NS Medical Staff Writer

08 Sep 21

Delta-Cages and DoubleWedge-Cages are intended for intervertebral body fusion procedures for various diseases of the lumbar spine, such…

RegulationApprovals

FDA approves Molekule’s Air Pro device to destruct viruses and bacteria

By NS Medical Staff Writer

03 Sep 21

The company has designed the Air Pro device for the protection of larger spaces and open floor plans…

RegulationApprovals

US FDA Grants Breakthrough Device Designation for Innovative EndoSound Vision Ultrasound System

By NS Medical Staff Writer

03 Sep 21

The EndoSound Vision System is an add-on device that consists of a compact ultrasound beamformer, reusable transducer, and…

RegulationApprovals

Asensus Surgical Receives FDA 510(k) Clearance for Expansion of Machine Vision Capabilities

By NS Medical Staff Writer

03 Sep 21

The current features of the ISU enable machine vision-driven control of the camera for a surgeon by responding…

RegulationApprovals

Zimmer, Canary get FDA de novo authorisation for smart knee implant

By NS Medical Staff Writer

31 Aug 21

Persona IQ integrates Zimmer Biomet's Persona knee implant with Canary Medical's canturio te tibial extension sensor technology

RegulationApprovals

FDA approves MicroTransponder Vivistim Paired VNS System

By NS Medical Staff Writer

30 Aug 21

Vivistim is claimed to be the first-of-its-kind system to treat moderate to severe upper extremity motor deficits associated…

RegulationApprovals