FDA Clears Multi-Device ECG Analysis Software for Extended Monitoring

Electrocardiogram (ECG) monitoring using traditional Holter systems and newer wearable patches can generate recordings spanning days or even weeks. Clinical teams therefore need consistent analytics and efficient review across data captured by different devices. A newly cleared software version now supports ECG analysis periods ranging from one minute to 14 days for both Holter and wearable patch recordings.

ZBPro Diagnostic v2.0 from ZBeats Inc. (Stony Brook, NY, USA) has received U.S. Food and Drug Administration (FDA) 510(k) clearance (K261580). The software expands the company’s independent analysis platform to support ECG recordings from one minute up to 14 days. It accommodates Holter configurations and wearable patches, enabling use across diverse recording devices.

The platform performs automated retrospective beat and rhythm analysis, including detection of atrial fibrillation. It unifies review, editing, and structured reporting within an intuitive technician interface. The software also incorporates the company’s NoiseGuard and a common intelligence layer to produce consistent, clinically meaningful outputs across supported technologies.

Flexible workflows and configurable permissions are designed to help clinical teams standardize review and advance studies efficiently from analysis to final report. These features target operational efficiency for high‑volume independent diagnostic testing facilities (IDTFs) and healthcare networks. The newly cleared version will be showcased at HRX Live 2026 in Atlanta, scheduled for September 18–20.

“This clearance advances our vision for independent ECG intelligence. ZBPro combines NoiseGuard with a common intelligence layer that transforms data from supported recording technologies into consistent, clinically meaningful analysis at scale. By separating ECG intelligence from the hardware, ZBPro creates a flexible foundation for clinical research, monitoring centers, and consumer wearables,” said Bin Fang, Ph.D., CEO and co-founder of ZBeats, Inc.

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