[Edaily Reporter SONG YOUNG-DOO ] SEERS TECHNOLOGY(458870), a wearable artificial intelligence (AI) diagnostic and monitoring company, announced on the 29th that its wearable electrocardiogram (ECG) device, “mobiCARE,” has received 510(k) clearance from the U.S. Food and Drug Administration (FDA).

This clearance is significant not only because it marks the completion of regulatory procedures for sales in the U.S., but also because it enables SEERS to advance its U.S. business strategy faster than expected. The company had submitted its final FDA 510(k) application in May and anticipated approval in the third quarter of this year, but by securing clearance in late June, it has established a foothold in the U.S. market ahead of schedule.

Consequently, the company’s preparations for its U.S. “Medical Concierge”-based ECG testing service are also expected to accelerate. SEERS has been pursuing a strategy of collaborating with local medical institutions to conduct outpatient proof-of-concept (PoC) trials, followed by entry into the U.S. Medicare reimbursement market.

With FDA approval coming earlier than expected, the outpatient proof-of-concept schedule can now begin ahead of schedule, and the company expects that the subsequent steps—securing Medicare reimbursement and commercialization—will proceed as planned.

The United States is one of the world’s largest markets for arrhythmia diagnosis. More than 14 million arrhythmia tests are performed annually, and the Medicare-based reimbursement rate for long-term ECG monitoring is approximately $250 per test—about five times the level of domestic insurance reimbursement rates. As demand for long-term ECG monitoring is growing rapidly due to an aging population and an increase in cardiovascular diseases, the digital healthcare market—combined with AI-based analysis services—is assessed to have high growth potential.

This FDA approval is expected to have a positive impact not only on the U.S. market but also on the company’s global business expansion. Since FDA approval is regarded as one of the most authoritative medical device certifications worldwide, it can serve as a key reference during future product approval and business negotiation processes in overseas markets such as the Middle East and Asia.

Following its recent supply contract in the United Arab Emirates (UAE) and the securing of U.S. FDA approval, SEERS plans to accelerate its global business expansion. Having proven the commercial viability of its AI-based inpatient monitoring platform “thynC” in the domestic hospital market, the company’s strategy is to position Mobicare as a key driver to cultivate the U.S. and the Middle East as its two major global growth pillars.

Based on the clinical data, AI analysis technology, and hospital operational experience accumulated in Korea, the company aims to emerge as a global AI healthcare platform company, focusing on the U.S. Medicare market and GCC countries.

Lee Young-shin, CEO of SEERS, stated, “With this FDA approval, we have laid the groundwork to validate our AI ECG analysis platform—which has already proven its commercial viability in Korea—in the U.S. market as well.” He added, “We will proceed without delay with pilot programs in U.S. outpatient settings and our entry into the Medicare market, and based on this, we will gradually expand our global business.”