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.
CEO Bin Fang frames the update as a bet on hardware-independent ECG intelligence
"This clearance advances our vision for independent ECG intelligence," said Bin Fang, PhD, CEO and co-founder of ZBeats. He said ZBPro pairs its NoiseGuard noise-filtering technology with a common intelligence layer that converts data from supported recording devices into standardized, clinically meaningful output, separating ECG analytics from the underlying hardware for use across clinical research, monitoring centers, and consumer wearables.
Platform bundles automated arrhythmia detection with technician-facing review tools
ZBPro combines automated retrospective beat and rhythm analysis, including atrial fibrillation detection, with review, editing, and reporting functions built into a technician interface. Configurable permissions and standardized workflows are designed to help clinical teams move studies from analysis to final report more efficiently, a capability aimed at high-volume independent diagnostic testing facilities (IDTFs).
ZBeats to demonstrate the cleared version at HRX Live 2026 in Atlanta
The company will showcase ZBPro v2.0 at HRX Live 2026, running September 18-20 at the Signia by Hilton Atlanta. Attendees can view the platform and schedule meetings with ZBeats' executive team during the event.