Wellysis has won FDA clearance for S-Patch CardioAI, an AI-powered Software as a Medical Device that reads arrhythmias straight out of the electrocardiogram data its S-Patch wearable already records. The Seoul-headquartered, Samsung SDS-spun-off company announced the clearance on 8 October 2026, thirteen days after FDA's 25 September decision — a software layer added to hardware it had cleared three years earlier, aimed at the remote-monitoring companies and diagnostic labs that already run the patch rather than at patients buying a new device.
CardioAI's clearance in four figures
Figures from Wellysis' 8 October 2026 announcement and prior FDA clearance records.
The software half of a 2023 clearance
Wellysis already had FDA clearance for the hardware CardioAI reads. The S-Patch Ex, a lightweight, waterproof single-lead ECG patch, was cleared in August 2023 (510(k) K231289); the S-Patch ExL followed in February 2024 (K233906), extending continuous wear to roughly fourteen days on one battery charge. CardioAI adds an AI interpretation layer on top of that recording hardware: FDA's 25 September 2026 clearance covers the algorithm, classified as a Class II device under 21 CFR 870.1425 (Programmable Diagnostic Computer), not a new sensor.
That sequencing matters for how fast the product can reach the market Wellysis is selling into. Because the ECG-acquisition hardware was already cleared, CardioAI's review turned on the performance of the software alone — whether it reliably flags arrhythmias from data FDA had already accepted as clinically usable, rather than on a new device's safety and acquisition accuracy.
“This clearance is an important milestone in expanding the capabilities of the S-Patch solution in the U.S.” Young Juhn, co-founder and CEO, Wellysis — 8 October 2026 announcement
Who builds on a cleared algorithm
CardioAI is not an app patients download. Under its cleared indications, Wellysis licenses the algorithm to the organizations that already run S-Patch in the field — remote patient monitoring providers, Independent Diagnostic Testing Facilities and clinical research organizations — to build into their own web and mobile applications. That is a bet on volume through other companies' distribution rather than a Wellysis-branded consumer product, and it mirrors how Wellysis has grown the hardware side: a 2025 partnership with Artella Solutions launched a remote cardiac monitoring service in the U.S. built on S-Patch rather than a Wellysis-run clinic network.
Three things that shape where CardioAI fits
Built on hardware already cleared
CardioAI layers AI arrhythmia evaluation onto the S-Patch Ex and ExL patches FDA had already cleared in 2023 and 2024, so this review turned on the algorithm alone rather than a new sensor's acquisition accuracy.
Sold through other companies' apps
The cleared indication is for RPM providers, IDTFs and CROs to embed CardioAI in their own platforms — Wellysis is a software supplier to that chain, not a direct-to-patient brand.
Heading to KOSDAQ, not Nasdaq
With about $30 million raised, including a $13.5 million pre-IPO round, Wellysis is targeting a listing on Korea’s KOSDAQ exchange in Q4 2026 or Q1 2027 — a different capital market than most of this desk’s device Spotlights.
A software layer inside a $3.3 billion forecast
AI-read electrocardiograms are a small but fast-growing slice of cardiac monitoring. Separate research firms size the opportunity differently depending on what they count: as a standalone software category, or bundled with the remote-monitoring hardware and services it rides on. Both point the same direction — up, steeply — which is the case for a company selling the algorithm rather than the patch.
AI-read ECGs, two ways of counting the market
$844M → $3.3B
Global AI ECG platform market, 2024 to 2030, as forecast by GII (25.4% CAGR); shown against the broader remote cardiac monitoring market Meticulous Research sizes at $4.68B in 2026.
Sources: GII, Artificial Intelligence (AI) ECG Platform — Global Market Trajectory & Analytics · Meticulous Research, Remote Cardiac Monitoring Market
Regulatory News outlook
We expect AI interpretation to become a standard add-on to ambulatory ECG hardware rather than a separately marketed product, with a cleared, licensable algorithm like CardioAI positioned to take a mid-single-digit share of the $3.3 billion 2030 AI-ECG-platform figure without needing its own sensor clearance.
How we got here: GII's own $844 million 2024 base compounds to its $3.3 billion 2030 figure at roughly 25% a year; a licensed algorithm reaching even 5% of that 2030 total implies about $165 million in annual software revenue across all licensees combined, which we treat as a plausible ceiling for a single cleared platform competing against several others.
CardioAI against how else an ECG gets read
| Product | Function | FDA status | How it reaches patients |
|---|---|---|---|
| Wellysis S-Patch CardioAI | AI arrhythmia evaluation on S-Patch ECG data | 510(k) cleared, Sep 2026 (K254255) | Licensed to RPM providers, IDTFs, CROs |
| Anumana ECG-AI | AI disease-risk screening (low ejection fraction, amyloidosis, pulmonary hypertension) from a standard 12-lead ECG | 510(k) cleared, multiple indications 2023–2026 | Distributed via Philips’ ECG AI Marketplace |
| iRhythm Zio | Ambulatory ECG patch with centralized, clinician-reviewed arrhythmia detection | FDA-cleared hardware and reporting service | Sold direct to health systems |
| AliveCor KardiaMobile | Consumer single/six-lead ECG with on-device AI rhythm classification | FDA-cleared consumer device | Sold direct to consumers and clinics |
From each company’s published clearances and product materials; not a clinical comparison.
From a Samsung SDS spinout to a KOSDAQ filing
Wellysis’ road to a software clearance
- 2019
Wellysis founded
Spun off from Samsung SDS’s Digital Health division in Seoul, South Korea.
- 30 August 2023
S-Patch Ex cleared
FDA 510(k) clearance (K231289) for the single-lead ECG patch hardware.
- 16 February 2024
S-Patch ExL cleared
FDA 510(k) clearance (K233906) extending continuous wear to roughly 14 days.
- 2025
Artella Solutions partnership
Launch of a remote cardiac monitoring service in the U.S. built on the S-Patch platform.
- 25 September 2026
CardioAI cleared
FDA 510(k) clearance (K254255) for the AI arrhythmia-evaluation software, classified Class II.
- 8 October 2026
Clearance announced
Wellysis publicizes the CardioAI clearance via press release.
- Q4 2026 – Q1 2027
KOSDAQ listing targeted
Wellysis is working toward a public listing on Korea’s KOSDAQ exchange.
What a licensed algorithm still has to prove
A software clearance is not a sales contract. Wellysis has not disclosed which RPM providers, IDTFs or CROs will be first to embed CardioAI, what it will charge them, or how it will measure the review-time savings it is implicitly promising. Those commercial terms, not the clearance itself, decide whether CardioAI becomes a meaningful software line or a feature that sits mostly unused inside S-Patch's existing customer base.
- No new indication beyond arrhythmia evaluation: CardioAI's cleared scope is analyzing ECG data for arrhythmias — not the broader “clinical interpretation, workflow efficiency and scalable cardiac analysis” platform Wellysis has described in funding materials.
- KOSDAQ timing: the targeted Q4 2026–Q1 2027 listing window is Wellysis’ own target, not a filed prospectus date.
- Commercial terms undisclosed: pricing, launch customers and expected adoption inside the existing RPM/IDTF/CRO base have not been published.
Sources & further reading
- U.S. Food and Drug Administration, 510(k) clearance letter, S-Patch CardioAI, K254255, 25 September 2026. accessdata.fda.gov
- Wellysis, “Wellysis Secures FDA 510(k) Clearance for AI-Powered ECG Analysis Software, S-Patch CardioAI,” press release via PRNewswire, 8 October 2026 (reproduced). technode.global
- MassDevice, “Samsung spinoff Wellysis wins FDA nod for wearable ECG,” 2026. massdevice.com
- Wearable Technologies, “Korean ECG Patch Gets FDA Clearance,” on the 2023 S-Patch Ex clearance. wearable-technologies.com
- Asian Hospital & Healthcare Management, “Innovative remote cardiac monitoring service launched in the US by Wellysis and Artella Solutions.” asianhhm.com
- GlobalInfoResearch (GII), “Artificial Intelligence (AI) ECG Platform — Global Market Trajectory & Analytics.” giikorea.co.kr
- Meticulous Research, “Remote Cardiac Monitoring Market.” meticulousresearch.com
Regulatory News reports on public regulatory documents. It is not legal advice, and the primary sources above govern. If we have made an error, we will say so in public: see corrections.
Frequently asked questions
What did FDA clear for Wellysis?
S-Patch CardioAI, an AI-powered Software as a Medical Device that analyzes ECG data from the company's S-Patch wearable patch and evaluates it for arrhythmias. FDA cleared it as a Class II device (510(k) K254255) on 25 September 2026; Wellysis announced the clearance on 8 October 2026.
Does a provider need new hardware to use CardioAI?
No. CardioAI runs on ECG data already captured by the S-Patch Ex and S-Patch ExL, hardware Wellysis had separately cleared in 2023 and 2024. No new sensor clearance was required.
Can patients buy CardioAI directly?
Not under this clearance. It is licensed to the organizations that already deploy S-Patch — remote patient monitoring providers, Independent Diagnostic Testing Facilities and clinical research organizations — for them to build into their own web and mobile applications.
Is Wellysis publicly traded?
No. It is privately held, with about $30 million raised to date including a $13.5 million pre-IPO round, and is working toward a listing on Korea's KOSDAQ exchange in the fourth quarter of 2026 or the first quarter of 2027 — not a U.S. exchange.
