Medical Devices Enter the Software Era as Software Accounts for 61% of Innovative Medical Devices

As of July this year, software-based medical devices accounted for 61% of all designated innovative medical devices, highlighting the growing role of software in the medical device industry. The Ministry of Food and Drug Safety (MFDS) stated that it is exploring ways to provide benefits for innovative medical devices in public procurement processes.

On the 4th, the MFDS announced that it had designated 13 products as innovative medical devices by July this year, including digital therapeutics that leverage digital health technologies such as big data, artificial intelligence (AI), wearables, mobile applications, and virtual reality (VR).

Innovative medical devices are defined as medical devices that apply highly advanced technologies—such as information and communication technology (ICT), biotechnology, and robotics—or introduce improved methods of use. These devices significantly enhance, or are expected to enhance, safety and effectiveness compared to existing medical devices or treatment methods.

Of the 13 innovative medical devices designated this year, eight products (approximately 61%) were medical device software. This was followed by four products (31%) in the “instruments and machinery” category and one product (8%) classified as an in-vitro diagnostic medical device. The medical device software designated this year includes technologies such as electrocardiogram (ECG) analysis for left ventricular dysfunction and software for improving mild cognitive impairment.