Wearable artificial intelligence (AI) diagnostic monitoring company Seers announced on Tuesday that it has completed the final document submission for the U.S. Food and Drug Administration (FDA) 510(k) approval of its wearable AI electrocardiogram analysis solution, mobiCARE (mobiCARE™).
This submission marks the final step in the FDA approval process, with a decision on approval expected soon. FDA 510(k) is a U.S. medical device approval procedure that evaluates substantial equivalence to existing approved medical devices, allowing for sales in the U.S. market upon approval.
mobiCARE is a wearable patch-based electrocardiogram analysis solution that diagnoses and analyzes arrhythmia signs using AI-based analysis. It is currently being used in over 1,000 medical institutions in South Korea, with the cumulative number of arrhythmia diagnoses surpassing 700,000.
The company is recognized as having secured the largest number of references and electrocardiogram data in the domestic wearable AI electrocardiogram analysis field.
In the U.S., Seers is pursuing entry into the Medicare reimbursement market through medical concierge-based outpatient verification. Medicare is a public healthcare insurance system in the U.S. for the elderly, and the arrhythmia diagnosis market has a higher reimbursement structure compared to South Korea, suggesting that mobiCARE’s overseas sales will significantly expand after market entry.
Seers has prepared in advance for collaboration with local medical partners and distribution channels, as well as establishing service operation models, to ensure immediate entry into the U.S. market upon obtaining FDA approval. As a result, the company expects to launch its business operations immediately after approval without any additional preparation time.
A Seers representative stated that the completion of the final document submission to the FDA indicates that it has entered the final stage of a crucial procedure for entering the U.S. market. It plans to swiftly expand the AI diagnostic business based on mobiCARE in the U.S. market, following the success in the Middle East.
In related news, Seers recently launched mobiCARE in Vietnam. This marks Seers’ third overseas base after the United Arab Emirates (UAE) and the U.S., signaling the start of its global expansion with a recurring revenue-based service model.
Seers has secured its first reference by partnering with Vietnam’s largest pediatric hospital, the National Children’s Hospital (NCH) under the Ministry of Health, where it is conducting a pilot program.
The technology has been utilized in actual electrocardiogram diagnosis processes in an environment where continuous monitoring is crucial for pediatric patients, successfully completing technological verification in a public healthcare setting. Ongoing tests are expected to maintain stable demand, primarily within the hospital network.
Notably, the business model has expanded beyond hospital-centered implementations to include screening centers, establishing a structure for growing service revenue based on the number of tests conducted.