What You Should Know
- ECG-led diagnostics software pioneer AccurKardia and Samsung SDS spin-off Wellysis have executed a multi-year agreement in Seoul to launch a turnkey cardiac monitoring solution in the United States.
- The strategic alliance pairs Wellysis’ S-Patch wearable ECG monitor directly with AccurKardia’s cloud-based automated analytics to streamline Holter, extended Holter, and mobile cardiac telemetry (MCT) clinical workflows.
- All biometric telemetry captured by the wearable is evaluated by AccurECG 2.0, a hardware-neutral, FDA-cleared Class II software as a medical device (SaMD) that generates clinician-ready diagnostic reports in minutes.
- Built on a 99% accuracy baseline across FDA-cleared arrhythmia classifications, the combined offering gives cardiology and general medicine groups an end-to-end mechanism to reduce medical technologist data curation hours.
- The partnership leverages Wellysis’ global distribution pipeline, which already spans over 2,000 active clinics and hospitals worldwide, and follows initial vendor approvals finalized in mid-2025.
Operating at the Analytical Edge: Accelerating Throughput via AccurECG 2.0
The architectural core driving this international commercial roll-out moves beyond generic signal visualization tools to enforce a rigid, hardware-neutral system of predictive text composition and near-real-time rhythm triage. All continuous electrical signals captured by the lightweight, waterproof Wellysis S-Patch device are streamed into AccurECG 2.0, AccurKardia’s enterprise-grade, FDA-cleared Class II software as a medical device (SaMD) platform.
The technical synergy across the clinical monitoring landscape scales through a tightly coordinated end-to-end execution loop:
1. High-Fidelity Signal Capture
The lightweight Wellysis patch, powered by a specialized Samsung Bio-Processor chip, resides on the patient’s chest for extended wear periods, collecting continuous heart rate data and raw electrophysiological signals.
2. Algorithmic Ingestion & Triage
The telemetry data flows directly into AccurKardia’s cloud infrastructure, where its core engine carries out automated beat-by-beat analysis and ventricular/supraventricular ectopic detection.
3. Rhythm Classification Sorting
AccurECG 2.0 evaluates the incoming signal across 13 unique rhythm classifications—including atrial fibrillation, atrial flutter, and ventricular tachycardia—delivering a 99% accuracy rate across cleared arrhythmia boundaries.
4. Direct Workflow Automation
The software synthesizes these data streams into a complete, structured diagnostic report, immediately uploading it to a cloud-accessible portal ready for final physician sign-off without manual copy-paste adjustments.
“By combining the S-Patch with our automated, FDA-cleared ECG analytics platform, we are giving clinicians a complete, ready-to-use monitoring solution that fits directly into their workflow,” stated Juan C. Jimenez, co-founder and CEO of AccurKardia. “It is a strong validation of our platform and the value we can deliver to partners bringing high-quality cardiac monitoring to market at scale.”
The commercial alignment between these two digital health organizations leverages a robust global distribution network. Founded as a spin-off from Samsung SDS’s Digital Health division, Wellysis has scaled its ambulatory monitoring business across international lines, with over 2,000 healthcare systems and clinics worldwide utilizing its diagnostic hardware architecture.
The multi-year agreement builds upon initial system integrations completed in April 2025 and subsequent vendor approvals finalized in June 2025, establishing an unassailable data-activation pipeline tailored specifically for the competitive U.S. clinical diagnostic market.
Young Juhn, Chief Executive Officer of Wellysis, emphasized that this clinical collaboration permanently alters how data-heavy cardiac signals enter the patient chart. Juhn re-affirmed that bringing the S-Patch together with an automated analytical core gives U.S. practices a true turnkey option.
Furthermore, AccurKardia continues to advance an investigational pipeline of ECG-based biomarkers, including its AK-AVS™ for aortic stenosis risk assessment and AK+ Guard™ for hyperkalemia screening—both of which have secured FDA Breakthrough Device Designation, with AK+ Guard recognized as the “Best New ECG Technology Solution” at the 10th annual MedTech Breakthrough Awards.
