ZBeats Receives FDA Clearance for ZBPro Diagnostic v2.0, Supporting ECG Analysis Up to 14 Days
Expanded platform supports wearable patches across diverse recording devices; Company to showcase new capabilities at HRX 2026 in Atlanta.
STONY BROOK, N.Y., Sept. 15, 2026 /PRNewswire/ -- ZBeats Inc. today announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance (K261580) for its ZBPro Diagnostic v2.0 software. This clearance expands ZBeats' independent ECG analysis platform to support recordings from one minute up to 14 days, including Holter configurations and wearable patches. The ZBeats team will showcase the newly cleared version this week at HRX Live 2026 in Atlanta, Georgia.
Experience ZBPro v2.0 at HRX 2026
Attendees can explore the platform's capabilities or schedule a meeting with the ZBeats executive team at HRX Live 2026, taking place September 18–20 at the Signia by Hilton Atlanta. Visit hrsonline.org/event/hrx-live-2026.
"This clearance advances our vision for independent ECG intelligence," said Bin Fang, PhD, CEO and co-founder of ZBeats, Inc. "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."
ZBPro combines automated retrospective beat and rhythm analysis, including detection of atrial fibrillation, with advanced review, editing, and reporting tools in an intuitive technician interface. Flexible workflows and configurable permissions help clinical teams standardize review and move studies efficiently from analysis to final report, improving operational efficiency for high-volume IDTFs.
About ZBeats Inc.
ZBeats Inc. is a medical technology leader in independent, cloud-native ECG intelligence solutions. Founded in 2019 and headquartered in Stony Brook, New York, the company specializes in device-agnostic software that transforms raw electrocardiographic data into structured clinical intelligence. ZBeats' FDA-cleared flagship platform, ZBPro Diagnostic, combines AI-driven analysis with review and reporting tools, maximizing operational efficiency for clinical research, IDTFs, and healthcare networks. Learn more at zbeats.co.
SOURCE ZBeats Inc.
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