[Edaily Reporter Shin Ha-yeon ] SEERS TECHNOLOGY(458870), a wearable artificial intelligence (AI) diagnostic and monitoring company, has secured product approval for its wearable AI electrocardiogram (ECG) analysis solution, “mobiCARE™,” in Canada, following its approval in the U.S., and is now moving to commercialize the product in the North American market.

SEERS announced on the 7th that mobiCARE™ has obtained a Class II Medical Device License (MDL) from Health Canada.

This approval covers the entire mobiCARE integrated system, including the wearable ECG device, electrodes, and software for both healthcare providers and patients. The company submitted its application on June 26 and received approval on the 3rd of this month (local time).

Following its U.S. Food and Drug Administration (FDA) 510(k) clearance in June, SEERS has now secured a Canadian product license, laying the groundwork for entering key North American markets. The company plans to sequentially expand its product licenses to Europe, Australia, Southeast Asia, and the Gulf Cooperation Council (GCC) region in the future.

Mobicare is a solution that supports the diagnosis of arrhythmias by allowing patients to measure their ECG while maintaining their daily routines and analyzing the collected data using AI algorithms. According to the company, it is currently used in approximately 1,100 medical institutions in South Korea, with cumulative test counts exceeding 770,000 and ECG analysis time surpassing 39 million hours.

SEERS’ strategy for expanding its overseas business is to build service models tailored to each country’s healthcare and insurance systems based on Mobicare, which has been commercialized in South Korea.

In North America, the company is preparing to launch a testing service business linked to local diagnostic networks in the U.S. and Medicare reimbursement rates. In Canada, where public insurance reimbursement rates apply to long-term ECG testing, the company plans to develop a commercialization model in collaboration with local medical institutions and partners based on this product approval.

The company is pursuing a two-track strategy: fostering its AI inpatient monitoring platform “thynC™” as a growth engine in the domestic market and developing “MobiCare” as a growth engine overseas.

Lee Young-shin, CEO of SEERS, stated, “Following FDA approval and our entry into the UAE market, securing this Canadian approval marks the beginning of the full-scale commercialization of Mobicare’s global business starting in the second half of the year.” He added, “Based on the product competitiveness validated in the domestic market and our large-scale data assets, we will achieve tangible business results in North America and the Middle East and expand overseas sales as a new growth engine.”