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 Food and Drug Administration's White Oak campus in Silver Spring, Maryland. (Maansi Srivastava/ For The Washington Post via Getty Images) Six days after a senior FDA official sent a sweeping ...
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 ...
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 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 ...
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 ...
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