Business Wire

RapidAI Secures FDA 510(k) Clearance for Groundbreaking AI 3D Head and Neck CTA Imaging: Lumina 3D™

SAN MATEO, Calif.--(BUSINESS WIRE)--RapidAI, the global leader in AI-driven medical imaging analysis and coordinated care, has received FDA 510(k) clearance for Lumina 3D™ by RapidAI—an industry-first ...
Business Wire

BlueWind Medical Receives FDA 510(k) Clearance for Enhanced Revi® Wearable Supporting Long-Term Treatment of Urgency Urinary Incontinence

Enhanced wearable builds on Revi’s strong clinical evidence, meaningful symptom relief, and exceptionally high patient satisfaction. SALT LAKE CITY--(BUSINESS WIRE)--BlueWind Medical, Ltd., a leader ...
BioSpace

Zephyrus Innovations™ announces US FDA 510(k) clearance for VaporShield™ CSTD

VANCOUVER, BC, Dec. 16, 2025 /CNW/ -- Zephyrus Innovations (Zephyrus), a privately-owned medical device company designing and manufacturing safety syringes and Closed System Transfer Devices (CSTDs), ...
urologytimes

FDA grants 510(k) clearance to enhanced Revi System for urgency urinary incontinence

The Revi System, an implantable tibial neuromodulation device, received FDA 510(k) clearance for its enhanced version, improving urgency urinary incontinence treatment. The OASIS trial confirmed the ...
Seeking Alpha

HeartSciences Announces FDA 510(k) Submission for MyoVista® wavECG™ Device

Southlake, TX, Dec. 15, 2025 (GLOBE NEWSWIRE) -- HeartSciences Inc. (HSCS) (Nasdaq: HSCS; HSCSW) (“HeartSciences” or the “Company”), a healthcare information ...
IGN

The 34" Alienware Ultra-Wide OLED Gaming Monitor Drops to a New Lowest Price (Less than Black Friday)

During Black Friday, Dell lowered the price of its venerable 34" Alienware AW3423DWF QD-OLED gaming monitor from $900 to just $499.99 shipped. That was a new historical price low, but today there's a ...