S-Patch CardioAI gets FDA 510(k) clearance for ECG analysis
Wellysis received FDA 510(k) clearance for S-Patch CardioAI, its AI software that analyzes ECG data and evaluates arrhythmias, on September 25, 2026, and announced it from Houston on October 8, 2026. The Class II clearance adds AI analysis to the company's S-Patch wearable ECG monitor and lets other health companies build it into their own web and mobile apps. For remote monitoring providers and testing facilities, the task it targets is ECG review, which grows with every patient monitored.
Why ECG review strains monitoring providers
The problem Wellysis is addressing is the review work behind wearable heart monitoring. A patch records a patient's electrocardiogram, and someone has to analyze that data and find the arrhythmias in it. The company says that as ECG monitoring volumes continue to grow, healthcare organizations are looking for ways to manage ECG review workflows more efficiently.
Until now, Wellysis covered only the first half of that job. Its S-Patch wearable series already had FDA clearance for ECG acquisition, meaning recording the signal. The analysis was left to the customer's own tools.
What the FDA cleared on September 25, 2026
The FDA granted 510(k) clearance to CardioAI as a Class II medical device, with a decision of substantially equivalent. The agency's database lists it under 510(k) number K254255, classified as a programmable diagnostic computer under regulation number 870.1425, with product code DQK and a subsequent product code of DPS. The FDA received the submission on December 29, 2025, and the cardiovascular panel reviewed it.
CardioAI is Software as a Medical Device: it is designed to analyze ECG data and evaluate arrhythmias. Wellysis announced the clearance from Houston on October 8, 2026.
How CardioAI fits into existing ECG workflows
The software is built to run inside other companies' products. Under the cleared indications for use, healthcare solution providers can build CardioAI into web and mobile applications, so remote patient monitoring providers, Independent Diagnostic Testing Facilities, Clinical Research Organizations and other health companies can add AI-powered ECG analysis to their current operations.
Wellysis says the analysis settings and deployment options are flexible, so the software can adapt to different customer environments. It is designed to automate ECG analysis and support healthcare professionals as they review and interpret the data, not to replace them.
"This 510(k) clearance is an important milestone in expanding the capabilities of the S-Patch solution in the U.S." — Young Juhn, CEO of Wellysis
How Wellysis plans to sell the software
The commercial plan starts with the existing customer base. Wellysis plans to introduce CardioAI to current S-Patch customers in the US and then offer it to diagnostic testing facilities, research organizations, remote monitoring providers and other healthcare organizations.
It plans two pricing models: recurring subscriptions and per-test fees. Both sit alongside the existing S-Patch hardware business, so a customer can buy the recording device, the analysis or both.
What Wellysis has achieved in the US so far
No measured result for CardioAI has been published yet; the release gives no accuracy, review-time or customer figures for the new software. The company's track record comes from the patch business. Wellysis was spun off from Samsung SDS in 2019 and set up a Houston-based subsidiary, Wellysis USA Inc., in 2023.
It operates from the Texas Medical Center Innovation facility after being selected for Johnson & Johnson's JLABS program, and it serves testing facilities, research organizations and other providers. The company says its US revenue more than quadrupled from 2024 to 2025.
What it changes for remote cardiac monitoring businesses
For a remote monitoring provider or testing facility, the task S-Patch CardioAI handles is the first pass of ECG analysis, the step that grows with every new patient on a patch. Because it can be built into third-party platforms, a provider can add cleared AI analysis to the software it already runs instead of switching systems, and pay per test or by subscription. Until Wellysis or its customers publish review-time figures, the value is the task it covers rather than a proven saving.
Questions and answers
What is S-Patch CardioAI?
It is Wellysis' AI-powered Software as a Medical Device that analyzes ECG data and evaluates arrhythmias. It received FDA 510(k) clearance as a Class II device on September 25, 2026.
Who can use CardioAI?
Healthcare solution providers can build it into web and mobile apps. Wellysis names remote patient monitoring providers, Independent Diagnostic Testing Facilities and Clinical Research Organizations as target users.
How will Wellysis charge for CardioAI?
The company plans to offer recurring subscriptions and per-test pricing, alongside its existing S-Patch hardware business.
MOZGII view
How we would build it
AI helps most in medicine where the volume of data outruns the people who must read it, and heart monitoring is a clear case. A wearable patch records continuously, and every new patient adds hours of signal to read. Software that does the first pass lets technicians and cardiologists spend their time on the strips that need a decision.
If we were building that first-pass layer, we would start with recordings that cardiac technicians have already labeled, tied to the final report a physician signed. The model would mark and sort events by urgency; a technician would confirm each finding, and a physician would sign the report. Because CardioAI is meant to sit inside other companies' software, we would also log which version of the model produced each result, so a provider can trace any report back to the software that read it.
It would break on signal quality. A patch that slips or a patient who moves produces noise that can look like an arrhythmia or hide one. We would have the system say plainly when a recording is too poor to read rather than guess. The one metric we would watch is how often technicians change the software's findings, by type of event, because that shows where the model is weak.
Next, we would build a feedback path from each provider's corrections into the review set, with patient consent and privacy controls, so the analysis improves in the settings where it is used.
Sources
Where the facts in this story come from.
- 01Wellysis Secures FDA 510(k) Clearance for AI-Powered ECG Analysis Software, S-Patch CardioAIprnewswire.com
- 02Wellysis Secures FDA 510(k) Clearance for AI-Powered ECG Analysis Software, S-Patch CardioAIprnewswire.com
- 03Wellysis Secures FDA 510(k) Clearance for AI-Powered ECG Analysis Software, S-Patch CardioAIprnewswire.com
- 04Wellysis Secures FDA 510(k) Clearance for AI-Powered ECG Analysis Software, S-Patch CardioAIprnewswire.com
- 05510(k) Premarket Notificationaccessdata.fda.gov