Medical Devices

Simplex Quantum and University of Tokyo Introduce AI-Based Heart Failure Monitoring System

The new HF-index enables accurate, on-demand heart failure severity tracking using single-lead ECG data from wearable devices....

XOD Appoints Kelly Hermans as Clinical Excellence Leader Amid Launch of WONDER TOUCH™ Device

First-of-Its-Kind, FDA-Approved, Needle-Free, Portable Radio Frequency Device Now Available in the U.S. Market ...

CereVasc's eShunt® System Receives FDA Breakthrough Device Designation for Pediatric Use

Innovative endovascular treatment for communicating hydrocephalus gains regulatory support for patients aged 12 and older....

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. ...