HME Square’s non-invasive glucose monitoring device, GlucoSOUND, has been officially designated as an Innovative Medical Device (No. 116) under the Advanced Technology Category by the Ministry of Food and Drug Safety (MFDS) of Korea.

This designation recognizes GlucoSOUND’s technological innovation — the first in Korea to combine photoacoustic (PA) technology with AI-based signal analysis algorithms to measure blood glucose levels without needles or finger-pricking.

The Innovative Medical Device designation is granted by the MFDS to products that demonstrate proven technological excellence and clinical necessity. Designated devices are eligible for various regulatory benefits, including clinical trial design support, expedited review processes, and priority evaluation.