AccurECG 2.0 will serve as the automated ECG analytics and reporting engine in collaboration with Wellysis’ S-Patch, delivering a complete, clinician-ready monitoring solution for U.S. practices and health systems

NEW YORK & SEOUL: #BetterOutcomes--AccurKardia, Inc., an ECG-led diagnostics software company, and Wellysis, a digital healthcare company and developer of the S-Patch wearable ECG monitor, today announced a multi-year agreement under which AccurKardia’s AccurECG 2.0 will power the analytics behind Wellysis’ turnkey cardiac monitoring offering in the U.S. The agreement, which was signed last week in Seoul, is the latest between the two companies.

Under the agreement, Wellysis’ S-Patch wearable device will be paired with AccurKardia’s automated ECG analytics and reporting platform to deliver a complete, clinician-ready solution for Holter, extended Holter, and mobile cardiac telemetry workflows. All data is analyzed by AccurECG 2.0, AccurKardia’s FDA-cleared Class II software as a medical device, and delivered in a report ready for physician review. The combined offering gives U.S. cardiology and general medicine practices access to a seamless, end-to-end monitoring solution that integrates hardware, analytics and reporting into a single workflow delivering patient reports faster to improve outcomes. The agreement between AccurKardia and Wellysis follows the integration of the companies’ platforms in April 2025, with AccurKardia becoming an approved vendor to Wellysis in June 2025.

“This partnership demonstrates the power of close collaboration between two teams committed to improving cardiac care,” said Juan C. Jimenez, co-founder and CEO of AccurKardia. “We are excited to serve as the analytics engine powering Wellysis’ offering in the U.S. 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. 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.”

“From the beginning, our goal at Wellysis has been to make high-quality, accessible ECG monitoring a reality for clinicians and patients everywhere,” said Young Juhn, chief executive officer of Wellysis. “Bringing our S-Patch together with AccurKardia’s automated analytics and reporting platform allows us to offer a truly turnkey solution to the U.S. market. AccurKardia has been a solid partner throughout our collaboration, and we are excited to build on that foundation as we expand together in the United States.”

About Wellysis

Wellysis is a digital healthcare company dedicated to revolutionizing patient care through innovative ECG monitoring solutions. The company was founded in 2019 as a spin-off from Samsung SDS’s Digital Health division by a team of experts with extensive experience in the healthcare field. Its flagship product, S-Patch, is a user-friendly, wearable ECG monitor that provides real-time data and advanced analysis, empowering clinicians and patients alike. The company has successfully expanded its business to overseas markets, with over 2,000 hospitals and clinics using the product worldwide.

About AccurKardia

AccurKardia is an ECG-led diagnostics software company focused on transforming ECG data into a more powerful diagnostic tool and broad biomarker to improve patient outcomes and save lives globally. With initial applications in cardiology, the company offers transformative, cloud-based device-agnostic tools, including AccurECG™ 2.0, an FDA-cleared Class II software as a medical device (SaMD) for fully automated, near real-time ECG interpretation. AccurKardia is also advancing an investigational pipeline of ECG-based biomarkers, including AK-AVS™ for aortic stenosis risk assessment and AK+ Guard™ for hyperkalemia risk assessment using Lead I ECG, both of which have received FDA Breakthrough Device Designation. AK+ Guard was awarded the “Best New ECG Technology Solution” in the 10th annual MedTech Breakthrough Awards in 2026. For more information, please visit www.accurkardia.com.

Disclaimers:

For detailed technical AccurECG 2.0 requirements, relevant disclosures, and approved indications for use, please refer to the U.S. FDA 510(k) K252361 summary and product labeling. For additional details on S-Patch, please refer to FDA 510(k) K233906 and K231289.

Fonte: Business Wire