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 ...
Healio

FDA grants 510(k) clearance to AI-powered delirium screening device

Please provide your email address to receive an email when new articles are posted on . The device is the first to gain FDA clearance to monitor delirium. The device’s algorithm was validated with ...
MassDevice

CMR Surgical wins FDA clearance for next-gen Versius Plus surgical robot in cholecystectomy

The Versius Plus surgical robotics system [Image courtesy of CMR Surgical] CMR Surgical announced today that its second-generation surgical robot, Versius Plus, received FDA 510(k) clearance. Versius ...
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 ...
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 ...
Business Insider

3D Systems Announces FDA 510(k) Clearance Expanding VSP Orthopedics Indications to Include Skeletally Mature Adolescents

ROCK HILL, S.C., Dec. 15, 2025 (GLOBE NEWSWIRE) -- 3D Systems (NYSE: DDD) today announced that the U.S. Food and Drug Administration has granted 510(k) clearance expanding the indications for its VSP ...
kffhealthnews

Covid Vaccines Might Soon Come With Cautionary FDA ‘Black Box’ Label

Dr. Vinay Prasad, the FDA's director of the Center for Biologics Evaluation and Research, is said to be making plans to unveil by the end of this year a plan to include the most serious warnings on ...
BioSpace

Vesalio Receives FDA 510(k) Clearance of enVast, the First Stent-Based Coronary Thrombectomy Technology

The FDA clearance of enVast redefines coronary thrombectomy treatment and further expands Vesalio's commercial platform. PLANO, Texas, Dec. 11, 2025 /PRNewswire/ -- Vesalio, a leader in thrombectomy ...
FiercePharma

Italian nonprofit lands FDA approval for 1st gene therapy to treat rare genetic disease

The FDA has issued its stamp of approval to a new, cell-based option to treat Wiskott-Aldrich syndrome (WAS), marking the first therapy of its kind for the rare disease and making Italy’s Fondazione ...
BioSpace

Ceribell Receives FDA 510(k) Clearance for First-of-its-Kind Delirium Monitoring Solution

Novel technology paves the way for use of the company's industry-leading point-of-care electroencephalography (EEG) system to address long unmet need in delirium monitoring SUNNYVALE, Calif., Dec. 09, ...