ZBeats Receives FDA Clearance for ZBPro Diagnostic v2.0

ZBeats announced on September 15, 2026, that the FDA granted 510(k) clearance K261580 for ZBPro Diagnostic v2.0.

The cloud-based ECG analysis software supports retrospective recordings ranging from one minute to 14 days, including Holter recordings and single-lead wearable ECG patches.

The system is intended for qualified healthcare professionals analyzing compatible ambulatory ECG data in adults. It is not cleared for pediatric use, paced signals, real-time monitoring, alarms, emergency use, or standalone diagnosis.

ZBeats says the software will support automated analysis, professional review, reporting, and API-based integration. The company’s website indicates commercial availability is not expected until the second quarter of 2027.

The clearance is separate from ZBPro MCT; it does not establish FDA clearance for the company’s mobile cardiac telemetry product.