Medical Devices

Cortechs.ai Secures Health Canada Approval for AI Imaging Expansion

The regulatory milestone paves the way for broader adoption of its neuroimaging solutions across North America....

LifeSignals Launches UbiqVue™ Holter System with UltraLinQ at Heart Rhythm 2025

Single-use, 2-channel wearable Biosensor, patient-facing app and cloud-based system enable final Holter reports in hours—not days. ...

Theranica's Nerivio® Wearable Migraine Device Secures Coverage from Major U.S. Health Insurer

The policy expands access to this effective, non-drug treatment for members as young as 8 years old who are diagnosed with migraine ...

USA: Minder® Becomes First FDA-Approved Implantable Continuous EEG MonitorUSA: Minder® Becomes First FDA-Approved Implantable Continuous EEG Monitor

The FDA has granted authorisation for Minder under its De Novo pathway creating a new classification of device, allowing for marketing and sale of the device in the US for patients with drug resistant epilepsy...

U.S.: Sight Sciences to Debut OMNI® Edge Surgical System at 2025 ASCRS Annual Meeting

New system features higher viscoelastic capacity and TruSync™ technology, engineered to safely synchronize surgical control and precision in implant-free, comprehensive MIGS ...

BD Launches Next-Gen Hemodynamic Monitoring with AI-Powered Decision Support in the U.S.

New system enhances real-time patient assessment, enabling clinicians to make faster, data-driven decisions. ...

RND Automation Expands U.S. Presence with Acquisition of QuickPouch

RND Automation (RND), a subsidiary of CAS Holdings (CAS), is excited to announce the successful acquisition of QuickPouch's intellectual property and assets. ...

Medtronic’s Simplera Sync™ Sensor for MiniMed™ 780G System Gets FDA Approval – U.S.

The all-in-one, disposable sensor aims to streamline diabetes management with improved comfort and ease of use....

FDA Approves WiSE® System in U.S. – World's First Leadless LVEP Device for CRT

The revolutionary WiSE® technology introduces a new era in cardiac resynchronization therapy with a fully leadless left ventricular pacing solution....

Imidex’s FDA-Cleared Lung Cancer Detection Algorithm Acquired – U.S.

The sale marks a pivotal move in advancing early-stage lung cancer diagnosis through AI-powered radiology solutions....