Medical Devices

Baebies Receives FDA Breakthrough Device Designation for First Point-of-Care Heparin Monitoring Test

FINDER® platform enables rapid, low-volume Anti-Factor Xa testing, transforming anticoagulation care at the bedside....

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....