Digital healthcare company Huino announced on the 14th that its blood oxygen saturation measuring medical device 'MEMO Band' has received medical device approval from the Ministry of Food and Drug Safety (hereinafter referred to as the MFDS).
MEMO Band is a wearable pulse oximeter consisting of a wrist-worn body and a finger sensor, and can measure blood oxygen saturation (SpO₂) for up to 5 days continuously. The heart rate and oxygen saturation values measured by this device are displayed in real time on the display, and are simultaneously transmitted via wireless communication to the patient comprehensive control system of Huino’s electrocardiogram monitoring solution ‘MEMO Cue’ to support remote monitoring by medical staff.
This product is registered with the Health Insurance Review & Assessment Service as a ‘transcutaneous blood oxygen saturation measurement (E7230)’ item, so it can be billed, which can help alleviate the financial burden on patients.
Huino expects that the scope of MEMO Band’s application will expand beyond continuous vital signs monitoring of hospitalized patients to long-term care facilities or management of chronic patients at home. In particular, although there is currently no home healthcare fee system in Korea, if it is institutionalized in the future, the utilization of MEMO Band in the field of remote patient monitoring is expected to increase. In addition, the company plans to advance into overseas markets such as the US and Japan, where home healthcare infrastructure is already established.
Huino CEO Gil Young-jun said, “This MFDS approval is the result of acknowledging the safety and efficacy of the MEMO Band, and it has further solidified the foundation of a clinical decision support system based on real-time bio-signal data in medical settings.” He added, “We will continue to provide clinically meaningful information in hospitals and at-home settings through the MEMO Band, and to advance the treatment support system linked to artificial intelligence technology.”
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