Regulatory Approvals

Patient Enrollment to Begin Within Three Months Cerus Endovascular Ltd., a privately held, commercial-stage medical device company, today announced that the U.S. Food and Drug...

ROSA® System is used for Robotically-Assisted Partial Knee Arthroplasty. Leader in musculoskeletal healthcare, Zimmer Biomet, has received FDA 510(k) clearance of the ROSA® Partial Knee System for...

A medical smartwatch for researchers and healthcare providers to collect continuous and objective data from patients, while enabling health monitoring at scale.  EmbracePlus by Empatica has...

CE mark enables commercialization of GenPulse™ in EU OncoSec Medical Incorporated (NASDAQ:ONCS) (the "Company" or "OncoSec"), a biotechnology company focused on cytokine-based intratumoral immunotherapies, announced...

Thrombectomy Device with Off-Circuit Mechanical Aspiration Design for Treatment of Undesirable Intravascular Material in Venous System and Peripheral Vasculature. AngioDynamics, Inc. (NASDAQ: ANGO), a leading...

The US Food and Drug Administration (FDA) has granted 510(k) approval to Chemence Medical’s redesigned Exofin fusion skin closure system. The US Food and Drug Administration (FDA)...

The Breakthrough Devices Program is a voluntary program for certain medical devices and device-led combination products that provide for more effective treatment or diagnosis...

The company's device promises to change the way medical imaging is used and make it much more widely available by cutting the cost. Israeli imaging...

Vision-based patient monitoring and management company will focus on skilled nursing facilities, where its technology service can help clinicians deliver safer, higher quality and...