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FDA pays Cognita Imaging $1.29M to test whether a jury of LLMs can grade radiology AI CurvaFix puts a 1.45 percent removal rate on its first 3,800 pelvic implants Science Corporation names Darius Shahida president as PRIMA starts selling in Europe Aptitude's Metrix COVID test clears 510(k) with three times the sensitivity of its EUA version Sempresto's smartphone epinephrine injector heads for a 505(b)(2) after FDA answers 10 pre-IND questions FDA drafts a guided PMA submission template and sets a November 17 comment deadline FDA keeps radiology AI on the 510(k) path and denies Harrison.ai's exemption petition FIZE Medical takes a first close on a $20M Series B with its Japanese distributor co-leading Emanate clears Perio PODS, an at-home hydrogel dressing for after scaling and root planing FDA pays Cognita Imaging $1.29M to test whether a jury of LLMs can grade radiology AI CurvaFix puts a 1.45 percent removal rate on its first 3,800 pelvic implants Science Corporation names Darius Shahida president as PRIMA starts selling in Europe Aptitude's Metrix COVID test clears 510(k) with three times the sensitivity of its EUA version Sempresto's smartphone epinephrine injector heads for a 505(b)(2) after FDA answers 10 pre-IND questions FDA drafts a guided PMA submission template and sets a November 17 comment deadline FDA keeps radiology AI on the 510(k) path and denies Harrison.ai's exemption petition FIZE Medical takes a first close on a $20M Series B with its Japanese distributor co-leading Emanate clears Perio PODS, an at-home hydrogel dressing for after scaling and root planing

510(k)

ZBeats clears ZBPro Diagnostic v2.0 and stretches ECG analysis to 14 days

MedDevice Startups Staff · 5 days ago · 2 min read · Via ZBeats release

ZBeats cleared ZBPro Diagnostic v2.0 under K261580 and announced it on September 15. The software now reads ECG recordings from one minute up to 14 days, which brings wearable patches inside the same clearance as Holter monitors.

The platform is device-agnostic. It performs automated retrospective beat and rhythm analysis, flags atrial fibrillation, and gives technicians review, editing and reporting tools. Buyers are clinical research groups, independent diagnostic testing facilities and health networks that want interpretation decoupled from whoever made the hardware.

The first ZBPro Diagnostic clearance landed in October 2025 and covered Holter interpretation. Going back for a second 510(k) eleven months later to widen the recording window is the cheaper path than trying to claim 14 days on a first submission with no cleared predicate of your own.

ZBeats was founded in 2019 and is based in Stony Brook, New York.

Questions & Answers

What is the K number for ZBeats ZBPro Diagnostic v2.0?

ZBPro Diagnostic v2.0 cleared under K261580. ZBeats announced the clearance on September 15, 2026.

What changed between ZBPro Diagnostic v1 and v2.0?

The first ZBPro Diagnostic clearance, announced in October 2025, covered Holter ECG interpretation. Version 2.0 extends the software to recordings from one minute up to 14 days, including wearable patch configurations.

What does ZBeats ZBPro Diagnostic do?

ZBPro Diagnostic is device-agnostic software that performs automated retrospective beat and rhythm analysis on ECG data, including atrial fibrillation detection, with review, editing and reporting tools for clinical teams. ZBeats is based in Stony Brook, New York.

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