ZBPro Diagnostic brings clinical-grade ambulatory ECG interpretation to a wide range of care environments, offering scalable, device-agnostic diagnostics amid growing strain on cardiology services.
STONY BROOK, NY — July 14, 2025 — ZBeats, Inc., a medical technology company advancing clinical grade ECG interpretation software, announced today that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its flagship platform, ZBPro Diagnostic, under submission number K243252.
ZBPro Diagnostic is a cloud-native, device-agnostic Holter ECG interpretation system that delivers medical-grade analysis and streamlined reporting in under ten minutes. It is now cleared for retrospective analysis of 24- and 48-hour Holter ECG recordings in adult, non-paced populations. The platform is designed to help providers meet diagnostic demand across high-volume health systems, distributed diagnostic services, and care settings facing limited access to cardiology specialists.
ZBPro replaces conventional Artificial Intelligence software, which falters under degraded signal conditions and requires intensive techinician review. Its Augmented Intelligence framework is purpose-built to maintain precision and consistency in the face of clinical diversity, rhythm variation, and signal noise—common challenges in real-world ambulatory ECG diagnostics.
“FDA clearance of ZBPro Diagnostic is a defining achievement for our team and our mission,” said Bin Fang, PhD, CEO of ZBeats, Inc. “We’ve developed a system that aligns with the challenges facing modern healthcare—supporting scalable cardiac diagnostics with clinical rigor, speed, and clarity. It’s a solution built not just for today’s needs, but for where the healthcare system is headed.”
ZBPro’s clearance was supported by one of the most comprehensive validation efforts in Holter ECG software, including testing on over 69 million heartbeats, 400,000+ arrhythmia episodes, and data from 4,000+ patients. Validation included high-volume clinical studies, targeted arrhythmia testing, and a first-of-its-kind Noise Stress Test Database simulating real-world signal degradation.
Across all testing environments, ZBPro demonstrated consistent high performance, including QRS detection sensitivity and PPV ≥ 99.8% and atrial fibrillation episode sensitivity ≥ 99.0%. The system was validated across five FDA-cleared Holter devices and 14 rhythm classes, affirming its reliability across a broad range of clinical scenarios.
“FDA clearance reflects our unwavering commitment to rigorous regulatory standards and patient-focused innovation,” said Christopher Ford, Vice President of Regulatory Affairs and Quality Assurance at ZBeats, Inc. “This milestone reinforces ZBeats’ role as a responsible and credible contributor to cardiac diagnostics and establishes a strong foundation for our continued growth in regulated clinical environments.”
Early Adoption Signals Strong Clinical Impact
“ZBPro Diagnostic provides superior arrhythmia detection with reports that are clear and easy to interpret,” said Xuming Dai, MD, PhD, FACC, FSCAI, New York, NY. “The system significantly streamlines workflow efficiency and reduces workload on office staff.”
“We conducted dozens of studies comparing manually scanned five-lead Holter reports with ZBPro Diagnostic’s reports,” said Qian Zhao, MD, FACC, Queens, NY. “The rhythm accuracy was spot on, and the arrhythmia detection yield was significantly superior.”
“ZBPro Diagnostic integrates smoothly into our workflow, and its user-friendly design ensures quick adoption by our staff,” added Tiffini Chalmers, Sr. Operations Manager, San Francisco, CA. “The analysis results are accurate, concise, and complete in ten minutes.”
About ZBeats, Inc.
ZBeats, Inc. develops cloud-native diagnostic technologies that deliver fast, scalable, and precise ECG interpretation aligned with enterprise healthcare workflows. Founded by a multidisciplinary team of engineers, cardiologists, and data scientists, the company is headquartered in Stony Brook, NY.
ZBeats’ technology was developed and validated with support from the National Science Foundation (NSF) and National Institutes of Health (NIH) through the SBIR program. In 2021, ZBeats completed a $1.25 million seed round, led by Camellia Venture Capital, with participation from early-stage digital health investors committed to advancing the future of diagnostic cardiology.
For more information, visit www.zbeats.co or contact support@zbeats.co.
Media Contact
Christopher Ford
Vice President, Regulatory Affairs and Quality Assurance
ZBeats, Inc. (via Zaliance Medical Solutions)
chris@zaliance.com | (916) 612-9954