ZBeats Receives FDA 510(k) Clearance for ZBPro Diagnostic
Camellia Venture Capital portfolio company ZBeats advances access to scalable Holter ECG interpretation with clinical-grade ambulatory monitoring technology
FDA 510(k) Clearance Details
About ZBPro Diagnostic Platform
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 brings clinical-grade ambulatory ECG interpretation to a wide range of care environments, offering scalable, device-agnostic diagnostics amid growing strain on cardiology services.
Augmented Intelligence Innovation
ZBPro replaces conventional Artificial Intelligence software, which falters under degraded signal conditions and requires intensive technician 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. 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."
— Bin Fang, PhD, CEO of ZBeats, Inc.
Comprehensive Validation Program
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.
Clinical Performance Metrics
- QRS detection sensitivity and PPV ≥ 99.8%
- Atrial fibrillation episode sensitivity ≥ 99.0%
- Validated across 5 FDA-cleared Holter devices
- Tested across 14 rhythm classes
- Over 69 million heartbeats analyzed
- 400,000+ arrhythmia episodes validated
Regulatory Excellence and Quality Commitment
"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 Clinical Adoption and Feedback
Healthcare providers who have implemented ZBPro Diagnostic report significant improvements in workflow efficiency and diagnostic accuracy:
"ZBPro Diagnostic provides superior arrhythmia detection with reports that are clear and easy to interpret. The system significantly streamlines workflow efficiency and reduces workload on office staff."
— Xuming Dai, MD, PhD, FACC, FSCAI, New York, NY"We conducted dozens of studies comparing manually scanned five-lead Holter reports with ZBPro Diagnostic's reports. The rhythm accuracy was spot on, and the arrhythmia detection yield was significantly superior."
— Qian Zhao, MD, FACC, Queens, NY"ZBPro Diagnostic integrates smoothly into our workflow, and its user-friendly design ensures quick adoption by our staff. The analysis results are accurate, concise, and complete in ten minutes."
— Tiffini Chalmers, Sr. Operations Manager, San Francisco, CACamellia Venture Capital Investment
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.
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.
Learn More About This Regulatory Milestone
Explore the full details of ZBEATS' FDA 510(k) clearance and discover more about our portfolio companies advancing healthcare technology.