Seers (458870) announced Monday that its wearable electrocardiogram (ECG) testing device "mobiCARE" has received 510(k) clearance from the US Food and Drug Administration (FDA). The company completed its final FDA 510(k) document submission in May.
The United States is one of the world's largest arrhythmia diagnosis markets, with more than approximately 14 million arrhythmia diagnostic tests conducted annually. Medicare-based ECG testing reimbursement is known to be about $250 per case, roughly five times Korea's insurance reimbursement rate. Demand for wearable-based long-term ECG monitoring is also expanding amid an aging population and rising cardiovascular disease.
With this FDA clearance, Seers plans to accelerate its push for medical concierge-based ECG testing services in the United States. The company is pursuing a strategy to enter the Medicare public insurance reimbursement market after conducting outpatient proof-of-concept (PoC) trials in cooperation with local medical institutions.
Seers expects the FDA clearance to have a positive impact not only on US market entry but also on its global business expansion. The company plans to use it as an important reference in product approval and business negotiation processes in overseas countries such as the Middle East and Asia.
"This FDA clearance has laid the foundation to verify in the US market our AI ECG analysis platform, whose business viability we have already proven domestically," Seers CEO Lee Young-shin said. "We plan to push forward with US outpatient trials and entry into the Medicare market without setbacks, and based on this, gradually expand our global business."
