ZBeats Receives FDA Clearance for 14 Day ECG Analysis

Sep 16, 2026
ZBeats received FDA clearance for ZBPro Diagnostic v2.0, expanding the ECG analysis platform to support recordings lasting from one minute to 14 days.

ZBeats received U.S. Food and Drug Administration 510(k) clearance for ZBPro Diagnostic v2.0, the company announced in a press release. The clearance expands the ECG analysis platform to support recordings lasting from one minute to 14 days, including Holter configurations and wearable patches.

ZBPro v2.0 provides automated retrospective analysis of beats and rhythms, including atrial fibrillation detection. It combines NoiseGuard with a common intelligence layer that converts data from supported recording technologies into a consistent format for ECG analysis.

The platform also includes tools for review, editing, reporting, configurable permissions, and clinical workflows. ZBeats, which describes ZBPro as combining AI driven analysis with review and reporting tools, plans to present the cleared version at HRX Live 2026 in Atlanta from 18 to 20 September.

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