SEOUL, Mar. 25 (Korea Bizwire) — A wearable to measure electrocardiogram (ECG) has received the green light from local health authorities, the watch’s manufacturer said Monday.
The approval is the first since the government adopted the so-called regulatory sandbox — a mechanism for developing regulations that keep up with the fast pace of innovation — in the ICT sector.
HUINNO Inc. said its MEMO Watch product became the country’s first wearable medical device certified by the Ministry of Food and Drug Safety.
The company first developed wearable ECG monitoring system in 2015, before the launch of Apple 4 by U.S. tech giant Apple Inc. The product, however, could not be sold here mainly because it was tied down by regulations.
Patients wearing the device will be able to send ECG data at any time of day to healthcare providers and receive medical counseling about their conditions, the company said.