medical device guru

Cardiovascular / Cardiology

Movano Health On Track to File First FDA Submission for its Smart Ring’s SpO2 and Heart Rate Data Following Successful Pivotal Hypoxia Trial

Movano Health, a purpose-driven healthcare solutions company at the intersection of medical and consumer devices, today announces successful preliminary results of its pivotal hypoxia trial, which was completed in conjunction with the University of California, San Francisco (UCSF) to assess the accuracy of its...

December 16, 2022

Orthopedics and Spine

Life Spine Announces FDA 510(K) Clearance for the TruLift® Lateral Expandable Spacer System and Lateral Plate System

Life Spine, a medical device company that designs, develops, manufactures and markets products for the surgical treatment of spinal disorders, announced that it has received clearance from the U.S. Food & Drug Administration (FDA) to market the TruLift Lateral Expandable...

December 16, 2022

Imaging Visualization & Navigation

2,000 AI-Driven, Intraoperative CT-Guided Procedures Completed with LungVision

Body Vision Medical, a leader in AI-driven, intraoperative imaging, announced that its LungVision™ AI-driven, intraoperative CT imaging system has now been used in 2,000 diagnostic bronchoscopy procedures worldwide. Body Vision Medical’s LungVision™ System uses artificial intelligence (AI) to transform X-ray images from...

December 14, 2022

Imaging Visualization & Navigation

NeurOptics’ Neurological Pupil index™ and Automated Pupillometry Included in Latest European Guidelines for Post-Resuscitation Care

NeurOptics’ Neurological Pupil index™ (NPi®) and automated pupillometry are now included in the updated 2021 European Resuscitation Council (ERC) and European Society of Intensive Care Medicine (ESICM) Guidelines for post-resuscitation care as an objective measurement supporting neurological prognosis in patients...

December 14, 2022

Cardiovascular / Cardiology

IRRAS Receives US FDA 510(k) Clearance for its Next Generation IRRAflow Control Unit

IRRAS, a commercial-stage medical technology company with a comprehensive portfolio of innovative products for neurocritical care, announced that it received regulatory clearance from the United States Food, Drug, and Administration (FDA) to active all of the functionality on the next...

December 12, 2022

Diagnostics & Healthcare News

Pennsylvania-based Highmark Inc. Joins Theranica’s Coverage with Evidence Program for Nerivio® Drug-Free Migraine Treatment Device

Theranica, a prescribed digital therapeutics company developing advanced neuromodulation devices for migraine and other pain conditions, announced that Highmark Inc. (Highmark), one of America’s leading health insurance organizations and an independent licensee of the Blue Cross Blue Shield Association, will conduct...

December 12, 2022

Diagnostics & Healthcare News

Promising Remote Patient Monitoring solution, Polso, Achieves 1st FDA Clearance

ChroniSense Medical Ltd. took a step towards its vision of transforming chronic care management with Polso™, the company’s Remote Patient Monitoring (RPM) solution, achieving 510(k) clearance from the U.S. Food and Drug Administration (FDA). Initial indications include monitoring of blood...

December 8, 2022

Surgery and Surgical Robotics

Lazurite is Recognized in the 2022 Medical Device Network Excellence Awards & Rankings for its ArthroFree™ System

Medical device and technology company Lazurite has received recognition from Medical Device Network Excellence Awards & Rankings, one of the largest, most prestigious, and widely recognized programs in the industry. Lazurite ranked as Commended for the Innovation, Product Launches and...

December 7, 2022

Surgery and Surgical Robotics

Activ Surgical Secures CE Mark Approval for ActivSight™ Intelligent Light

Activ Surgical, a digital surgery pioneer, announced that it is has received CE Mark approval for its ActivSight™ Intelligent Light (“ActivSight”). The CE Mark validates that ActivSight meets the requirements of the European Medical Devices Regulation, allowing Activ Surgical to...

December 6, 2022