ZBeats Gains FDA Clearance for Expanded ECG Analysis Platform
Stony Brook-based ZBeats Inc. has secured FDA 510(k) clearance for its ZBPro Diagnostic v2.0 software, a move that enables the platform to process electrocardiogram recordings spanning from one minute to 14 days. The update broadens the system's compatibility to include both traditional Holter monitors and modern wearable patches.
The company intends to debut these expanded capabilities at the HRX Live 2026 conference in Atlanta, running from September 18–20. By decoupling ECG intelligence from specific hardware, the software aims to provide a unified analysis layer for clinical research organizations and independent diagnostic testing facilities.
CEO Bin Fang stated that the platform utilizes a proprietary NoiseGuard technology to convert raw data into consistent, actionable clinical insights. The system automates rhythm analysis—specifically for detecting atrial fibrillation—while offering administrative tools that allow medical teams to standardize reporting workflows. Founded in 2019, ZBeats focuses on cloud-native solutions designed to streamline high-volume cardiac monitoring, ensuring that diverse recording technologies produce uniform diagnostic outputs.
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