Medical Devices

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. ...

Life Molecular Imaging Expands Neuraceq® Availability at PharmaLogic Salt Lake City

Enhanced the supply capabilities of Neuraceq® to increase patient access to beta-amyloid PET imaging ...

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. ...