VUNO said it has obtained the Ministry of Food and Drug Safety (MFDS) certification for Hativ P30, an artificial intelligence (AI)-based electrocardiogram (ECG) device for at-home use. 

VUNO has received certification from the Ministry of Food and Drug Safety (MFDS) for Hativ P30, an at-home electrocardiogram device.
VUNO has received certification from the Ministry of Food and Drug Safety (MFDS) for Hativ P30, an at-home electrocardiogram device.

The device analyzes ECG data to check normal sinus rhythm, atrial fibrillation, bradycardia, and tachycardia.

The small-sized device allows users to easily measure heart signals in 30 seconds anytime and anywhere. Users can check the analysis results through a connected mobile application.

The product is capable of six-lead precision measurement,  the company said. Its measurement method is simple and provides more accurate information than smart watches or wearables, it added.

With the approval of the device, VUNO plans to start its business-to-consumer (B2C) business in earnest. Also, the company plans to commercialize an at-home AI medical device equipped with VunoMed Deep ECG, AI-based ECG analysis software, which received an innovative medical device by MFDS in October last year.

VUNO said it would launch its integrated healthcare brand Hativ and expand its business area to chronic disease health management apps, blood pressure monitors, and thermometers.

"Hativ P30 is a product that combines VUNO's superior technology and ECG data analysis and research capabilities and can help users find cardiovascular diseases on time," VUNO CEO Lee Ye-ha said.

Copyright © KBR Unauthorized reproduction, redistribution prohibited