[NEWS] Bionet’s SonoMe: The First Wireless Ultrasound in South Korea to Receive EU MDR CE Marking

The Medical Device Regulation (“MDR”) represents the latest set of regulations governing the production and distribution of medical devices in Europe, replacing the previous Medical Devices Directive (“MDD”), which was in effect until May 2021. Compliance with MDR is mandatory for all medical device companies operating in the European market, with the transition to the new framework required by May 2024. Notably, the MDR documentation is more comprehensive and rigorous than the original MDD, placing a strong emphasis on product safety, hygiene, and post-market surveillance.

To meet these stringent requirements, Bionet meticulously underwent quality management and testing procedures, thereby its SonoMe earning the distinction of becoming the first South Korean wireless handheld ultrasound scanner to attain CE marking under MDR.

SonoMe is a portable ultrasound imaging diagnostic device that received certification from the South Korean Ministry of Food and Drug Safety (MFDS) in 2021 and obtained clearance from the U.S. Food and Drug Administration (FDA) in 2022. It is a wireless transducer-based product that can connect to mobile devices via Wi-Fi, offering exceptional portability, making it ideal for ultrasound scanning in a variety of clinical settings without constraints on time or space.

Bionet’s achievement of being the South Korean manufacturer of a wireless handheld ultrasound scanner to obtain EU MDR CE marking firstly holds immense significance. With this approval to enter the EU market, Bionet aims to actively promote the export of SonoMe products to the European region, thereby enhancing its competitiveness in the global market.