North America

HemoSonics Wins 2025 Medical Device Network Excellence Award in Marketing Category

Award recognizes HemoSonics’ impactful marketing and ability to communicate the value of its Quantra Hemostasis System, which provides comprehensive blood analysis detailing hemostasis in the operating room in less than 15 minutes ...

Avant Technologies and Ainnova Request FDA Pre-Submission Meeting for VisionAI Platform

Companies seek guidance on clinical trial design for AI-driven diabetic retinopathy detection, aiming for 510(k) clearance to enter U.S. market....

Nature Communications Medicine Publishes Positive Data for Lenire® Tinnitus Device

Retrospective study from Alaska Hearing & Tinnitus Center shows 91.5% responder rate and significant improvement in Tinnitus Handicap Inventory scores after 12 weeks of treatment....

TheraLight Introduces the New TheraLight FIT

Compact design and standard voltage compatibility bring professional-grade photobiomodulation therapy to more wellness centers and clinics nationwide. ...

HeartcoR Partners with Wellysis to Offer S-Patch Wearable ECG for Clinical TrialsHeartcoR Partners with Wellysis to Offer S-Patch Wearable ECG for Clinical Trials

This milestone partnership supports the mission of both organizations to improve clinical trials through advanced medical technology. ...

DELFI Diagnostics Showcases Advances in Early Cancer Detection and Monitoring at AACR Annual Meeting

Fragmentomics pioneer showcases DELFI-TF treatment monitoring solution alongside early detection capabilities at a premier oncology research event ...

Medtronic's Hugo™ Robotic Surgery System Achieves Key Milestone in U.S. Clinical Trial

Largest multi-center prospective Investigational Device Exemption (IDE) study for multi-port robotic-assisted urologic surgery in the U.S. presented as a late-breaker at the American Urologic Association annual meeting...

Medtronic's OmniaSecure™ Defibrillation Lead Receives FDA Approval for Right Ventricular Use

Adding to the Medtronic portfolio of catheter-based lead solutions, the novel OmniaSecure defibrillation lead allows for precise delivery and placement in the right ventricle ...

FDA Clears Clarius Prostate AI for Handheld Ultrasound-Based Prostate Assessment

First AI-powered tool for real-time prostate volume and PSA density measurement aims to streamline urologic diagnostics in primary care settings. ...

CIRCA Scientific's PeriCross™ Epicardial Access Kit Receives FDA 510(k) Clearance

CIRCA Scientific receives FDA 510(k) clearance for the PeriCross™ Epicardial Access Kit, a novel tine-based system designed to support controlled and efficient subxiphoid access to the pericardial space....