Wellysis Secures FDA 510(k) Clearance for AI-Powered ECG Analysis Software, S-Patch CardioAI

• Adds FDA-cleared AI analysis to Wellysis' S-Patch ECG monitoring solution, expanding its capabilities beyond ECG acquisition
• Enables FDA-cleared AI analysis of S-Patch ECG data to be integrated into third-party ECG platforms and existing clinical workflows
• Designed to streamline ECG review workflows by automating analysis and supporting more efficient interpretation by healthcare professionals

HOUSTON, Oct. 8, 2026 /PRNewswire/ -- Wellysis, a digital health company specializing in wearable electrocardiogram (ECG) monitoring, announced today that its AI-powered ECG analysis software, S-Patch CardioAI, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). The clearance was granted on September 25, 2026, as a Class II medical device.

S-Patch CardioAI is an AI-powered Software as a Medical Device (SaMD) designed to analyze ECG data and evaluate arrhythmias. Wellysis already provides FDA-cleared S-Patch hardware for ECG acquisition, and the addition of CardioAI brings FDA-cleared AI analysis to the S-Patch solution, extending Wellysis' capabilities from ECG acquisition through AI-powered analysis.

Under the FDA-cleared indications for use, healthcare solution providers can incorporate CardioAI into web- and mobile-based applications, enabling remote patient monitoring (RPM) providers, Independent Diagnostic Testing Facilities (IDTFs), Clinical Research Organizations (CROs), and other digital health and healthcare organizations to leverage AI-powered ECG analysis within their current operations.

With flexible analysis configuration and deployment options, CardioAI is designed to adapt to a variety of customer environments and operational requirements.

"This 510(k) clearance is an important milestone in expanding the capabilities of the S-Patch solution in the U.S.," said Young Juhn, CEO of Wellysis. "By combining our FDA-cleared ECG acquisition technology with FDA-cleared AI analysis, we can provide customers with a more integrated ECG monitoring solution while giving healthcare organizations the flexibility to deploy CardioAI according to their operational needs."

With this milestone, Wellysis plans to introduce CardioAI to existing S-Patch customers in the U.S. and expand its AI analysis offerings to IDTFs, CROs, RPM providers, and other healthcare organizations. The company plans to support recurring subscription and per-test commercial models for CardioAI, complementing its existing S-Patch business.

As ECG monitoring volumes continue to grow, healthcare organizations are seeking ways to manage ECG review workflows more efficiently. S-Patch CardioAI is designed to automate ECG analysis and support healthcare professionals in reviewing and interpreting ECG data, helping streamline workflows across a range of remote cardiac monitoring settings.

About Wellysis

Spun off from Samsung SDS in 2019, Wellysis is a wearable ECG monitoring company that develops the S-Patch wearable series, cloud-based analysis platforms, and AI-powered ECG analysis software. The S-Patch is used globally and has received regulatory clearances from the U.S. FDA and Korea's MFDS, as well as CE certification in Europe.

Wellysis has been expanding its U.S. presence through its Houston-based subsidiary, Wellysis USA Inc., established in 2023. Supported by a local sales team and operating from the Texas Medical Center (TMC) Innovation facility after being selected for Johnson & Johnson's JLABS program, the company currently serves Independent Diagnostic Testing Facilities (IDTFs), Clinical Research Organizations (CROs), and other healthcare providers. U.S. revenue more than quadrupled from 2024 to 2025.

For more information, visit www.wellysis.com.

SOURCE Wellysis