Medical Devices

Candela Launches Vbeam Pro® Laser Platform for Vascular and Dermatologic Conditions

FDA-cleared for pediatric use, the Vbeam Pro® combines 595 nm pulsed dye and 1064 nm Nd:YAG lasers to treat a wide range of skin conditions across all skin types. ...

SonoMotion Completes Pivotal Trial Enrollment for Break Wave™ System, Secures $2.2M NIH Grant

Procedure is designed to fragment kidney stones using low pressure ultrasound waves in fully awake patients, without anesthesia, in the office or clinic ...

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...