North America

Penumbra Secures FDA Clearance for Stroke Thrombectomy Platform

The THUNDERBOLT platform expands Penumbra’s computer-assisted vacuum thrombectomy technology into acute ischemic stroke care....

OraSure Gains FDA Clearance for At-Home STI Sample Collection Kit

The clearance supports decentralized urine sample collection for molecular STI testing using Roche’s cobas platforms....

A New Era of Implantable Photonic Devices for Targeted Cancer Care

The technology has demonstrated successful light transmission through tissue-mimicking models and represents a significant step toward more precise, patient-friendly cancer treatment...

Clarius Secures FDA Clearance for AI Cardiac Ultrasound Tool

The Ejection Fraction AI tool is designed to support real-time cardiac assessment in primary care and emergency settings....

Bright Uro Receives FDA Clearance for Glean Abdominal Sensor

The sensor expands Glean into wireless, catheter-free multi-channel urodynamics, targeting more comfortable and real-world bladder function testing. ...

E-Scopics Expands Hepatoscope Capabilities for Liver Disease Assessment

The FDA-cleared update adds spleen stiffness assessment, real-time elastography imaging and EHR connectivity, strengthening Hepatoscope’s role in point-of-care liver care. ...

Smith+Nephew Completes First Clinical Cases with CORI XT Handheld Robotics Platform

The next-generation platform extends handheld robotic assistance across knee and shoulder arthroplasty, supporting use in both hospital and ambulatory surgery centre settings. ...

Alife Health Receives FDA Clearance for AI-Powered Embryo Assessment Tool

Embryo Predict provides fertility specialists with adjunctive AI insight for embryo selection during IVF, supported by a multicentre randomised clinical trial. ...

Clarius Receives FDA Clearance for AI-Based Ejection Fraction Ultrasound Tool

The app-integrated tool automates left ventricular ejection fraction assessment, supporting real-time cardiac evaluation in primary care and emergency settings. ...

Waters Secures FDA Clearance for BD BACTEC FXI Blood Culture System

The automated system is now available in the US, offering faster bloodstream infection detection and higher vial-loading capacity for high-throughput microbiology laboratories. ...