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ZBeats, Inc. Receives FDA 510(k) Clearance for ZBPro Diagnostic, Advancing Access to Scalable Holter ECG Interpretation

Updated on October 13, 2025

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

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ZBeats Awarded National Science Foundation (NSF) SBIR Phase I Grant to Advance Cloud-Based ECG Analysis Platform

Stony Brook, NY – September 15, 2020 — ZBeats INC, a digital health startup focused on scalable cardiac diagnostic software, has been awarded a Phase I Small Business Innovation Research (SBIR) grant from the National Science Foundation (NSF). The award, totaling $256,000 under Award No. 2025951, supports ZBeats’ development of a cloudbased ECG analysis platform designed to improve the eRiciency and accessibility of longterm ambulatory cardiac monitoring.

The funded project centers on the creation of a machine-assisted ECG interpretation system that supports technicians and physicians in identifying arrhythmias more eRiciently and with greater clarity. The proposed solution includes rule-based and data-driven signal processing methods, complemented by annotation and review tools designed to enhance technician oversight and streamline the production of clinical reports.

“This NSF award reflects our commitment to building meaningful tools that support—not replace—clinical decision-making, By combining intelligent signal processing with workflow-focused tools, we hope to oRer providers new ways to manage long-duration ECG data with speed, accuracy, and transparency.”Dr. Bin Fang, CEO and Co-Founder

Exploring Anatomy & Physiology in the Lab

The ZBeats Phase I eRort focused on:

  • Developing rule-based and early-stage machine learning algorithms for beat detection and arrhythmia classification.
  • Evaluating performance of these algorithms using ANSI/AAMI EC57:2012 benchmarking standards.
  • Prototyping interactive annotation tools for use by cardiovascular technicians and clinicians.
  • Conducting early user evaluations with potential adopters to refine software usability and design.

The broader impact of this research lies in the potential to reduce delays and improve diagnostic yield in outpatient ECG monitoring, especially for patients at risk of arrhythmia related complications such as syncope, stroke, and sudden cardiac death. By oRering a vendor-neutral, cloud-based system that supports high-volume ECG review, ZBeats aims to help IDTFs, sleep labs, cardiology clinics, and remote patient monitoring (RPM) networks scale services while preserving the interpretive control of clinical teams. This award was made under the NSF’s rigorous review criteria, reflecting both the project’s technical merit and its potential for broader health and economic benefit.

Exploring Anatomy & Physiology in the Lab

ZBeats is a medical technology company focused on software innovation for ambulatory cardiac monitoring. Its platform integrates deterministic ECG analysis, techniciansupervised workflows, and hardware-agnostic compatibility to support scalable, cloudbased diagnostics.

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ZBeats Launches Feasibility Study of Cloud-Based ECG Diagnostic System for Long Term Monitoring

ZBeats Launches Feasibility Study of Cloud-Based ECG Diagnostic System for Long Term Monitoring

Most laboratory is a facility that provides controlled conditions in which scientific technological research, experiments, and measurement may be performed. Laboratories are found in a variety of privately owned research institutions, settings such as schools, universities, to research and testing facilities, government regulatory and forensic investigation centers, physicians offices.

The organization and contents of laboratories are determined by the differing requirements of the specialists working within. physic laboratory might contain a particle accelerator while a psychologist’s laboratory might be room with one-way mirror and hidden camera which to observe behavior. In some laboratories, such as those commonly used by computer scientists or vacuum chamber, while a metallurgy laboratory could a have apparatus for casting or refining metals or for testing their strength. A chemist or biologist might use a wet laboratory,

“Our goal is to close the diagnostic gap by making long-term ECG analysis more
accessible, eRicient, and clinically actionable,” said [insert responsible spokesperson].
“This study marks a critical step toward enabling more timely rhythm interpretation,
reduced costs, and expanded clinical use cases—especially in remote patient monitoring.”Founder and CEO

ZBeats’ prototype system, ZBPro™, has been validated against ANSI/AAMI EC57 benchmark datasets and internal test sets, showing high accuracy in arrhythmia detection using a rulebased engine. The feasibility study will gather data on operational performance, transmission reliability, and clinical integration over the course of real-world use.

With a vision of democratizing access to high-quality arrhythmia detection, ZBeats’ cloudbased model aims to reduce time-to-diagnosis from weeks to minutes, enhance
transparency for physicians, and support broad deployment across telehealth and outpatient care.

About ZBeats Inc.

ZBeats is a New York-based medical technology company developing cloud-based ECG software and wearable sensor integrations for ambulatory cardiac monitoring. The company’s mission is to bring scalable, clinician-centered solutions to healthcare systems, IDTFs, and digital health providers.

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ZBeats Selected by NIH to Exhibit Ambulatory Cardiac Monitoring Technology at VIVE Conference

ZBeats Selected by NIH to Exhibit Ambulatory Cardiac Monitoring Technology at VIVE Conference

Nashville, TN – March 26, 2023 — ZBeats, a digital health company advancing scalable solutions in cardiac diagnostics, is pleased to announce its selection by the National Institutes of Health (NIH) to exhibit at the VIVE Conference in Nashville, Tennessee. This sponsorship, extended through the NIH Small Business Innovation Research (SBIR) program, underscores ZBeats’ role in driving innovation in ambulatory ECG analysis and cloud-based diagnostic workflows.

At the conference, ZBeats will present its ZBPro Diagnostic software—an FDA-bound Software as a Medical Device (SaMD) designed to support technician-led ECG interpretation and report generation—as well as its early-stage wearable prototype, ZBPatch, developed to improve long-duration ECG recording for patients in outpatient and remote settings.

“We are proud to represent NIH-funded innovation at one of the industry’s leading health technology events,” said Dr. Bin Fang, CEO and Co-Founder of ZBeats. “This opportunity highlights our commitment to improving diagnostic eViciency and accessibility in cardiac care.”

 

Exhibit Highlights at VIVE 2023:

  • Technology Showcase: Live demonstrations of ZBPro Diagnostic and the betastage ZBPatch will highlight improvements in technician workflows, signal quality review, and scalable diagnostics.
  • SBIR-Driven Development: ZBeats will share outcomes from its NIH-funded research projects, including enhancements in ECG signal processing and long-wear
    device usability.
  • Interactive Engagement: Attendees can explore hands-on use cases and learn how ZBeats’ software platform integrates with electronic health record (EHR) systems and device data sources.
  • Partnership Opportunities: ZBeats welcomes engagement with clinics, IDTFs, research institutions, and digital health partners exploring advanced tools for ambulatory rhythm monitoring.

About ZBeats

ZBeats Inc. is a medical technology company focused on delivering software-driven solutions for ambulatory cardiac diagnostics. Its product suite spans Holter, extended Holter, and mobile cardiac telemetry use cases, with a focus on transparency, clinician oversight, and operational scalability. ZBeats is an NIH SBIR awardee and maintains development operations in New York.

About the NIH SBIR Program

The NIH Small Business Innovation Research (SBIR) program supports early-stage health and life sciences technologies with commercial potential. Its funding enables companies like ZBeats to bring high-impact innovations to market while advancing public health objectives.