FDA cleared the STEMI AI ECG Model from Powerful Medical, Inc. on Sep 3, 2026 under DEN250044, a direct 510(k). The review panel was Unknown.
FDA logged the submission as received on Sep 22, 2025. The decision came 346 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.
This is the only decision on file for Powerful Medical, Inc. in the last 12 months of the tracker.
DEN250044 is the FDA 510(k) for STEMI AI ECG Model, submitted by Powerful Medical, Inc.. FDA's decision date was Sep 3, 2026, under product code SHS.
Powerful Medical, Inc., based in New York, CA, is the applicant of record for DEN250044. The company is listed in the MedDevice Startups directory.
FDA received the submission on Sep 22, 2025 and issued its decision on Sep 3, 2026, 346 days later.
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