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. File that 1-minute-to-14-day / Holter / patch window as ZBeats’. This desk did not time a recording. Do not treat this as a new physical Holter box.

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. File that separate-intelligence-from-hardware picture as ZBeats’. This desk did not hook up a recorder.

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. File those analysis / review / report jobs as ZBeats’. This desk did not score a strip and is not inventing an accuracy percentage.

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. This desk did not bench noise rejection.

Named voice on the release: Bin Fang, PhD, CEO and co-founder of ZBeats, Inc. File the name and title as his, via ZBeats. 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. File that IDTF / high-volume-report picture as ZBeats’. This desk did not sit in a monitoring center.

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. File those dates and that venue as ZBeats’. This desk is not covering the conference as a separate filing.

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. File those history and location lines as ZBeats’. 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.

PRIMARY here: ZBeats’ 15 Sep 2026 PR Newswire company release — Tier A PRIMARY company source, the original record. The company site is product-home context, not a second originating newsroom. The 510(k) K261580 clearance for ZBPro Diagnostic v2.0, the one-minute-to-14-day analysis window, Holter configurations and wearable patches, the device-agnostic cloud / separate-intelligence-from-hardware frame, automated retrospective beat and rhythm analysis including atrial fibrillation detection, the review / editing / reporting technician tools, NoiseGuard and the common intelligence layer, the IDTF high-volume workflow line, the Fang title, the HRX Live 2026 Atlanta September 18–20 showcase, and the 2019 / Stony Brook about-box are company-attributed. AF / beat / rhythm analysis, NoiseGuard, and intelligence-layer marketing stay company-attributed — not independently audited here. NOT claimed: pricing, independently verified accuracy percentages, that this is a new physical Holter device, that this desk reviewed the FDA letter or scored a strip, a stock tip, or investment advice. Distinct from the already-filed xgrids-lixel-l3, ge-careintellect-operations, sorcero-fall-2026, powerful-medical-queen-of-hearts-fda-de-novo, microstructure-imaging-micsi-pet-fda, azmed-azchest-fda-6th, and sonus-medtronic-maternal-ultrasound-ai.