Regulator certifies VUNO ECG device for home use


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

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

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

The small-sized device allows users to easily measure heart signals within 30 seconds anytime and anywhere. Users can check scan results through a connected mobile app.

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

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

VUNO announced that it will launch its integrated health care 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 detect cardiovascular diseases in time,” said Lee Ye-ha, CEO of VUNO.


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