Diabeloop receives FDA 510(k) clearance for DBLG2, an Automated Insulin Delivery algorithm in an App: a strategic ...

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

Southlake, TX, Dec. 15, 2025 (GLOBE NEWSWIRE) -- HeartSciences Inc. (Nasdaq: HSCS; HSCSW) (“HeartSciences” or the “Company”), a healthcare information technology (“HIT”) company advancing the use of ...

In 2023, the FDA made the electronic Submission Template And Resource (eSTAR) mandatory for most 510(k) submissions. Although eSTAR is not an AI tool, the move was the first definitive leap toward the ...

Submission marks a key regulatory milestone toward bringing SEER-calibrated, imaging-based risk assessment to U.S. screening programs SEOUL, South Korea, Dec. 8, 2025 /PRNewswire/ -- Lunit (KRX:328130 ...

-- Submission covers multiple indications including general, urological, colorectal, gynecological and cardiac surgeries -- FORT LAUDERDALE, Fla., Dec. 08, 2025 (GLOBE NEWSWIRE) -- SS Innovations ...

SS Innovations said Monday it filed a 510(k) premarket notification with the Food and Drug Administration for its SSi Mantra surgical robotic system. In the submission, SS Innovations is seeking ...

The Vanquish Water Vapor System received FDA 510(k) clearance for prostate tissue ablation in intermediate-risk prostate cancer patients, showing promising early results. VAPOR 2 trial data ...

The clearnace was granted to the Ceribell System for electrographic seizure detection in newborns pre-term and older. FDA granted 510(k) clearance for Ceribell’s Clarity algorithm for electrographic ...

NEW YORK – Gradientech announced Wednesday that it has submitted a 510(k) premarket notification to the US Food and Drug Administration for its QuickMIC antimicrobial susceptibility testing platform.