SEERS, a wearable AI diagnostic monitoring company, said Monday that its AI-powered wearable electrocardiogram analysis solution mobiCARE has received a Class II Medical Device Licence (MDL) from Health Canada.
Health Canada granted the licence last Thursday (local time), following an application submitted on June 26, completing the regulatory process in just over two months. The approval covers the entire integrated system, including the wearable ECG device and electrodes, as well as software for healthcare providers and patients.
출처 : Korea Biomedical Review(https://www.koreabiomed.com)The Canadian approval follows U.S. Food and Drug Administration 510(k) clearance obtained in June, giving SEERS regulatory clearance in both the United States and Canada and laying the groundwork for commercialization across North America.
mobiCARE is a wearable AI-powered ECG analysis solution that allows patients to undergo ECG monitoring while carrying on with their daily activities. The collected data are analyzed using AI-based algorithms to support arrhythmia diagnosis.
According to SEERS, mobiCARE is the leading product in Korea’s wearable ECG monitoring market and is currently used by more than 1,100 medical institutions. It has handled more than 770,000 tests and accumulated over 39 million hours of ECG analysis.
SEERS said its overseas strategy centers on expanding mobiCARE, which has already been commercialized at scale and validated in Korea, rather than developing separate products specifically for overseas markets. The company plans to adapt its existing platform to the healthcare and reimbursement systems of individual markets.
SEERS is pursuing a two-track growth strategy, with its AI-powered inpatient monitoring platform thynC driving growth in Korea and mobiCARE serving as a new growth engine overseas.
In the U.S., the company is preparing a diagnostic testing service that combines local diagnostic networks with Medicare reimbursement. Canada also provides public reimbursement for extended ECG monitoring, and SEERS plans to use the new regulatory approval to develop commercialization models with local healthcare institutions and partners.
“With U.S. FDA clearance, our entry into the UAE market and now Canadian regulatory approval, mobiCARE’s global business is entering a full-fledged commercialization phase in the second half of this year,” SEERS CEO Lee Young-shin said.
“Based on the product competitiveness and extensive data assets we have built and validated in Korea, we aim to generate tangible business results in North America and the Middle East and develop overseas sales into a new growth engine,” Lee added.
