ZBeats says FDA cleared ZBPro to analyze ECG recordings up to 14 days

Why it matters

ZBeats can now pursue longer patch studies as well as Holter data, widening its market. Interoperability and workflow economics will determine whether its independent software layer wins deployments.

ZBeats, the Stony Brook ECG software developer founded by Bin Fang and Peng Zhang, said on September 15th that the Food and Drug Administration granted 510(k) clearance K261580 for ZBPro Diagnostic v2.0, expanding the software to recordings ranging from one minute to 14 days.

The expanded scope includes wearable patches and Holter configurations, according to ZBeats' announcement. ZBeats designed ZBPro to ingest ECG recordings from supported hardware, run retrospective beat and rhythm analysis, and give technicians tools to review, edit and produce reports. The software includes atrial fibrillation detection and a signal-processing feature ZBeats calls NoiseGuard.

Zhang brought an applied mathematics and high-performance computing background to the problem. A 2019 Stony Brook University biography identified him as a research scientist who earned his PhD in applied mathematics there after studying mathematics and parallel computing at Nankai University. His research combined mathematical models, machine learning and software for scientific and biomedical problems.

Fang has led ZBeats as CEO and served as its contact in the FDA record for the original ZBPro Diagnostic. His pitch for the new version is straightforward: ECG intelligence should function as a software layer rather than remain tied to whichever recorder happens to collect the signal.

"By separating ECG intelligence from the hardware, ZBPro creates a flexible foundation for clinical research, monitoring centers, and consumer wearables," Fang said in the announcement.

A wider scope than the first clearance

The September clearance represents a material expansion from the version the FDA cleared on July 10th, 2025.

The FDA summary for that earlier submission limited ZBPro Diagnostic to retrospective 24- or 48-hour recordings from three-lead and five-lead Holter systems using specified electrode and lead configurations. Its labeling explicitly excluded wearable patches, multi-lead analysis, pediatric patients and paced recordings.

That earlier version was intended for qualified healthcare professionals analyzing common arrhythmias in adult, non-paced patients. It processed ECG signals, detected QRS complexes and ventricular ectopic beats, calculated heart rate and R-R intervals, and supported manual annotation and report generation. The interpretation remained advisory and was not intended to serve as the sole basis for diagnosis.

ZBeats says v2.0 can process a far broader range of recording durations and supported recording technologies. That matters operationally because ambulatory ECG services increasingly receive data from a mix of traditional Holters, adhesive patches and third-party devices. A software layer capable of accepting those inputs can let a monitoring center standardize analysis and technician workflows without replacing every recorder.

The regulatory language also matters. A 510(k) clearance is based on substantial equivalence to a legally marketed predicate device. It is different from premarket approval, as the FDA explains in its 510(k) guidance.

The predicate for ZBeats' first clearance was the Cardiologs Holter Platform. That placed Fang and Zhang's product in direct regulatory comparison with a cloud ECG analysis system that already accepted data from several categories of ambulatory recording equipment.

Five years from seed funding to broader clearance

ZBeats was founded in 2019 and developed inside Stony Brook's technology community. A 2024 profile from Stony Brook University described ZBeats as an incubator participant with seven full-time and four part-time workers at the time. The profile said customers were seeking cloud software that avoided the installation and maintenance costs of conventional on-premise systems.

That was the commercial premise behind ZBeats' November 1st, 2021 seed round. ZBeats raised $1.25 million in a financing led by Camellia Venture Capital and said it would spend the money on product development and regulatory submissions. ZBeats also received federal small-business research support, including a 2022 award for feasibility testing of cloud-based ECG analysis for long-term ambulatory monitoring.

The first clearance arrived in July 2025. The second, according to the September 15th announcement, widens the set of recordings ZBeats can address. For a small medical software developer, that progression is the operating story: regulatory submissions are the product roadmap because each cleared input type or recording duration determines which customers can deploy the software.

ZBeats will demonstrate v2.0 at HRX Live 2026 in Atlanta from September 18th through September 20th. The timing puts the product in front of electrophysiologists, monitoring operators, engineers and device developers who could buy ZBPro directly or embed its analysis into another platform.

Duration is table stakes; interoperability is the bet

Fourteen-day monitoring is already established in ambulatory cardiology. iRhythm's Zio monitor, for example, continuously records ECG data for up to 14 days. Cardiomatics markets browser-based ECG analysis compatible with more than 60 Holter devices and offers analysis of recordings up to 14 days. Philips Cardiologs, the product used as ZBeats' earlier predicate, also sells cloud-based Holter analysis.

ZBeats therefore has to win on how easily monitoring centers and device manufacturers can connect hardware, move studies through technician review and produce consistent reports. Its planned product range reflects that approach: ZBeats markets versions for diagnostic testing facilities, remote patient monitoring, health-system integration and algorithm embedding in third-party devices.

ZBeats currently displays counters of more than 69 million heartbeats analyzed, 400,000 arrhythmia episodes detected and 4,000 patients supported on its website. Those are ZBeats' cumulative product metrics, and they do not establish current customer count, paid study volume or revenue.

The broader clearance gives Fang and Zhang a larger addressable pool of ECG data. The next task is commercial: convincing device makers and monitoring operators that an independent analysis layer can be easier to integrate and operate than the software bundled with an established recorder. ZBeats has spent seven years building toward that opening. ZBPro v2.0 gives the founders a wider regulatory foundation from which to test the bet.