ZBeats ZBPro v2.0 clears FDA for ECG analysis up to 14 days
ZBeats said the FDA cleared ZBPro Diagnostic v2.0 (510(k) K261580), expanding its device-agnostic ECG analysis software to support recordings from one minute up to 14 days — including Holter setups and wearable patches. The company will demo at HRX Live 2026 in Atlanta (Sep 18–20).
HEALTH desk — same-day FDA clearance that stretches cloud ECG analysis from one minute to two weeks across Holter recorders and wearable patches, without tying clinics to one hardware box.
What the clearance expands, as the same wire has it: ZBeats’ independent ECG analysis platform now supports recordings from one minute up to 14 days, including Holter configurations and wearable patches. A Holter is a multi-day wearable ECG recorder — typically a small device and leads a patient wears while going about ordinary life, so clinicians can catch rhythm problems that a short office tracing misses.
Product frame, still company: ZBPro is device-agnostic cloud software — it is meant to separate ECG intelligence from the recording hardware. Device-agnostic here means the same analysis layer can take data from different supported recorders instead of locking a clinic to one vendor’s box. The company says that creates a flexible foundation for clinical research, monitoring centers, and consumer wearables.
Features claimed, company — attribute, do not independently audit: automated retrospective beat and rhythm analysis, including detection of atrial fibrillation; advanced review, editing, and reporting tools in a technician interface; flexible workflows and configurable permissions so clinical teams can standardize review and move studies from analysis to final report. Atrial fibrillation, or AF, is an irregular heartbeat that can raise stroke risk. Retrospective here means the software reads a recording after it is captured, not that it replaces a bedside monitor.
NoiseGuard and the “common intelligence layer,” still company marketing — attribute: CEO Bin Fang says ZBPro combines NoiseGuard with a common intelligence layer that transforms data from supported recording technologies into consistent, clinically meaningful analysis at scale. File NoiseGuard, the intelligence-layer line, and “independent ECG intelligence” as ZBeats’ product language.
Named voice on the release: Bin Fang, PhD, CEO and co-founder of ZBeats, Inc. His quotes are color only beyond that attributed intelligence-layer line and stay in Sources.
IDTF workflow, company: the wire says those review tools are meant to improve operational efficiency for high-volume IDTFs. An IDTF is an Independent Diagnostic Testing Facility — an outpatient lab that runs diagnostic tests such as Holter and patch ECG studies and sends reports back to the ordering clinician.
Showcase, still company: the ZBeats team will showcase the newly cleared version at HRX Live 2026 in Atlanta, Georgia, September 18–20 at the Signia by Hilton Atlanta.
About-box context, optional and company-attributed: ZBeats Inc. Was founded in 2019 and is headquartered in Stony Brook, New York. It calls itself a medical-technology company in independent, cloud-native ECG intelligence, specializing in device-agnostic software that turns raw electrocardiographic data into structured clinical intelligence. Extra homepage marketing — including heartbeat counts and accuracy percentages — stays off this card.
Plain English for the rest of the card: ECG = electrocardiogram, the heart’s electrical tracing. Holter = a multi-day wearable ECG recorder. 510(k) = FDA clearance path for a device substantially equivalent to one already cleared. IDTF = Independent Diagnostic Testing Facility, an outpatient lab that runs tests such as Holter and patch studies. AF / atrial fibrillation = an irregular heartbeat that can raise stroke risk. device-agnostic = the same software can read supported recorders from more than one hardware vendor.
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On 15 Sep 2026 ZBeats Inc. Announced U.S. Food and Drug Administration 510(k) clearance (K261580) for ZBPro Diagnostic v2.0 software. The company PRIMARY is ZBeats’ PR Newswire release “ZBeats Receives FDA Clearance for ZBPro Diagnostic v2.0, Supporting ECG Analysis Up to 14 Days,” dated September 15, 2026, 22:12 ET, SOURCE ZBeats Inc., and datelined STONY BROOK, N.Y. A 510(k) is the common FDA path that clears a device as substantially equivalent to something already on the market. An ECG is an electrocardiogram — the heart’s electrical tracing. This is software clearance — not a new Holter recorder and not a new wearable patch. That company PRIMARY via PR Newswire is the filing event. These are company claims.