MobiCare, a wearable artificial intelligence (AI) electrocardiogram analysis solution, has secured medical device approval in Canada, following its earlier authorization in the U.S. This development lays the groundwork for the company’s expansion into the North American market.
On Monday, SEERS, a wearable AI diagnostics and monitoring firm, announced that MobiCare had received Class II medical device approval (MDL) from Health Canada.
This approval covers the entire MobiCare integrated system, including the wearable electrocardiogram device, electrodes, and software for both medical institutions and patients. SEERS applied for the approval on June 26 and received it in about two months.
Having previously obtained 510(k) approval for MobiCare from the U.S. Food and Drug Administration (FDA) in June, SEERS has now secured Canadian approval as well. This positions the company to commercialize its products in key North American markets, including the United States and Canada.
MobiCare is a wearable electrocardiogram solution that supports arrhythmia diagnosis. It uses AI algorithms to analyze data collected from electrocardiogram measurements taken while patients go about their daily activities.
In South Korea, MobiCare is currently used by approximately 1,100 medical institutions, with cumulative testing exceeding 770,000 cases. SEERS has amassed over 39 million hours of electrocardiogram analysis data.
SEERS aims to expand globally by introducing its domestically successful MobiCare to international markets. Rather than developing separate products for overseas use, the company plans to create service models tailored to different countries’ healthcare systems and insurance structures, leveraging its operational experience and AI analysis technology.
In North America, SEERS is preparing to launch a testing service that utilizes local diagnostic networks and insurance structures. The company is pursuing a business model linked to Medicare reimbursement in the U.S., while in Canada, it plans to collaborate with local medical institutions and partners to develop commercialization strategies that leverage the public insurance system for extended electrocardiogram testing.
Domestically, SEERS intends to focus on ThynC, its AI-based inpatient monitoring platform, as a growth engine. Internationally, the company will expand its business around MobiCare, which has already established a strong operational foundation in South Korea.
With the Canadian approval secured, SEERS also plans to extend its regulatory reach to Europe, Australia, Southeast Asia, and the Middle East.
Chief Executive Officer (CEO) Lee Young-shin stated that with FDA approval in the U.S., entry into the United Arab Emirates (UAE) market, and now Canadian approval, MobiCare’s global business is entering a significant commercialization phase starting in the second half of this year. It aims to achieve tangible business results in North America and the Middle East, leveraging the product’s proven competitiveness in the domestic market and our extensive data assets.
The name SEERS embodies the meaning of pioneer, reflecting the company’s founding philosophy. This ethos involves proactively anticipating changes in the healthcare landscape and creating innovative medical systems, even before digital healthcare became mainstream.