medical device guru

Surgery and Surgical Robotics

Xironetic Receives FDA Clearance for Augmented Reality Surgical Software

Xironetic, an early-stage healthcare technology company, today announced its IntraOpVSP™ augmented reality (AR) visualization software for complex surgeries has received clearance from the U.S. Food and Drug Administration (FDA). IntraOpVSP displays patient CT and MRI as three-dimensional holograms in AR...

November 14, 2022

Cardiovascular / Cardiology

ReCor Medical Announces Consistent Reduction of Blood Pressure in Pooled Analysis of Three Clinical Trials at AHA 2022

ReCor Medical, Inc. (“ReCor”) and its parent company, Otsuka Medical Devices Co., Ltd. announced consistent and significant blood pressure (“BP”) lowering results across a range of patients with uncontrolled hypertension, including across differences in age, sex, baseline blood pressure, medication...

November 10, 2022

Cardiovascular / Cardiology

Saranas Announces Over 1,200 Patients Treated with the Early Bird® Bleed Monitoring System

Saranas, Inc. announced that over 1,200 patients have been treated with the Early Bird® Bleed Monitoring System, the first and only FDA-approved bleed detection system. The Early Bird was launched in 2019 following a De Novo classification by the U.S....

November 9, 2022

Surgery and Surgical Robotics

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

Allotrope Medical™ Inc., a company committed to advancing surgical efficiency and safety, announced that they have received Safer Technologies Program (STeP) designation from the FDA for their surgical device StimSite. For the past year, StimSite has been used by surgeons...

November 7, 2022

Cardiovascular / Cardiology

Johnson & Johnson to Acquire Heart Pump Maker Abiomed

Johnson & Johnson, the world’s largest, most diversified healthcare products company, and Abiomed, a world leader in breakthrough heart, lung and kidney support technologies, announced that they have entered into a definitive agreement under which Johnson & Johnson will acquire...

November 2, 2022

Orthopedics and Spine

CurvaFix Receives FDA Clearance for Smaller-diameter, Intramedullary Implant for Pelvic Fracture Fixation

CurvaFix, Inc., a developer of medical devices to repair fractures in curved bones, announced it has received 510(k) clearance (K222505) from the U.S. Food & Drug Administration (FDA) for its smaller-diameter CurvaFix® IM Implant indicated for fixation of fractures of...

November 1, 2022

Orthopedics and Spine

NeuroOne® Receives FDA 510(k) Clearance to Market its Evo® sEEG System for Less than 30 Day Use

NeuroOne Medical Technologies Corporation, a medical technology company focused on improving surgical care options and outcomes for patients suffering from neurological disorders, announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance to market its Evo sEEG...

October 25, 2022

Surgery and Surgical Robotics

EndoStim Receives FDA Breakthrough Device Designation for the EndoStim System for the Treatment of Drug Refractory GERD

EndoStim, a medical device company developing and commercializing a first-in-class implantable neurostimulation treatment for drug refractory gastroesophageal reflux disease (GERD), announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Device Designation for the Company’s EndoStim System. FDA Breakthrough...

October 25, 2022

Diagnostics & Healthcare News

Eyenuk secures $26 Million Series A funding to accelerate global access to AI-powered eye-screening technology

Eyenuk, Inc., a global artificial intelligence (AI) digital health company and the leader in real-world applications for AI Eye Screening™ and AI Predictive Biomarkers™, announced it has secured $26 million in a Series A financing round, bringing the Company’s total...

October 20, 2022