Beatly AI LLC, the U.S. entity of Beatly.AI, announced it has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for C.R.A.V.E. (Cardiac Rhythm AI Visualization Engine ), its AI-based system for cardiac arrhythmia detection. The submission was filed on July 17, 2026, and Beatly is targeting FDA clearance around October 18, 2026.
C.R.A.V.E. is built on Beatly's core platform architecture: an AI-powered, device- and data-agnostic diagnostic engine designed to ingest and analyze ECG recordings from multiple manufacturers and file formats. Rather than building single-purpose hardware, Beatly develops AI diagnostics that plug directly into the cardiac monitoring devices clinics and hospitals already use - including Holter monitors, mobile cardiac telemetry (MCT), portable and wearable ECG devices, and standard 12-lead ECG systems - making integration into existing clinical workflows straightforward.
"Submitting our 510(k) for C.R.A.V.E. is a major milestone for Beatly and for the future of accessible cardiac diagnostics," said Aishwarya Sathyakumar, CEO, Beatly AI. "Our goal has always been to meet clinicians where they already work, using the devices they already trust, and give them faster, more dependable arrhythmia detection without forcing them into a new hardware ecosystem."
Beatly's platform combines proprietary artificial intelligence with expert clinical review. This human-in-the-loop model pairs the speed and scalability of AI with the judgment of experienced clinical professionals, helping healthcare organizations deliver diagnostic results that are both fast and clinically dependable.
