Wellysis, a digital health company specializing in wearable electrocardiogram (ECG) monitoring, announced 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 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."
