ZBeats Wins FDA Clearance for ZBPro v2.0, Expands ECG Analysis to 14 Days
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Stony Brook – September 18, 2026 -- ZBeats Inc. has secured U.S. Food and Drug Administration 510(k) clearance (K261580) for its ZBPro Diagnostic v2.0 software, extending its independent ECG analysis platform to cover recordings ranging from one minute to 14 days.
FDA clearance broadens device compatibility to Holter monitors and wearable patches
The updated clearance allows ZBPro to process data from a wider range of recording technologies, including Holter configurations and wearable patch devices, positioning the software as a device-agnostic layer for cardiac diagnostics providers.