NEW YORK - The US Food and Drug Administration granted 510(k) marketing clearances in November to Roche Molecular Systems, Cytovale, Truvian Health, and others for infectious disease pathogen ...
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 ...
The U.S. Food and Drug Administration has granted 510(k) clearance to 3D Systems, allowing its VSP Orthopedics virtual surgical planning and patient-specific instrumentation platform to benefit a ...
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 ...
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 ...
The Kricket system, powered by KPAP, treats obstructive sleep apnea (OSA). [Image courtesy of SleepRes] SleepRes announced today that it received FDA 510(k) clearance for its Kricket PAP device for ...
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 ...
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 ...
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), ...
Southlake, TX, Dec. 15, 2025 (GLOBE NEWSWIRE) -- HeartSciences Inc. (HSCS) (Nasdaq: HSCS; HSCSW) (“HeartSciences” or the “Company”), a healthcare information ...
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 ...
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 ...
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