Seers said on the 29th that it has obtained U.S. Food and Drug Administration (FDA) premarket clearance under 510(k) for its wearable electrocardiogram testing device "mobiCARE™." The 510(k) program certifies that a device has efficacy and safety at least equivalent to a legally marketed predicate device.
The company submitted its final documents for an FDA 510(k) filing in May, and received clearance at the end of June, about a month later. It had initially expected clearance in the third quarter of this year but said the timing was moved up.
Seers plans to use this clearance to push an electrocardiogram testing service in the United States in a Medical Concierge model. A medical concierge is a service model that manages the process before and after a visit to a medical institution and supports linkage to testing and treatment. After collaborating with local medical institutions to conduct outpatient proof of concept (PoC), the company aims to enter the Medicare reimbursement market.
The United States is a market where more than about 14 million arrhythmia diagnostic tests are performed annually. The Medicare-based electrocardiogram testing reimbursement is about $250 per case, roughly five times the level in Korea.
FDA clearance is expected to be leveraged not only in the United States but also for global business expansion. It can serve as a reference in overseas approval and business negotiations in regions such as the Middle East and Asia. Following a recent supply contract in the United Arab Emirates (UAE), the company expects that securing FDA clearance will accelerate global expansion.
Seers plans to validate its business model in Korea based on its AI medical platform "thynC™," and make mobiCARE a key pillar of its expansion into the U.S. and Middle Eastern markets. Based on clinical data accumulated in Korea, artificial intelligence (AI) analysis technology, and hospital operations experience, the company plans to expand its business with a focus on the U.S. Medicare market and Gulf Cooperation Council (GCC) countries.
Chief Executive Lee Young-shin of Seers said, "With this FDA clearance, we have laid the groundwork to use the AI electrocardiogram analysis platform validated in Korea in the United States as well," and added, "We will push ahead without a hitch with outpatient PoC in the United States and entry into the Medicare market."