MFDS Designates FieldCure iMET as Innovative Medical Device
Seoul, South Korea – September 25, 2025 – FieldCure announced that its electric field-based cancer therapy device, iMET, has been officially designated as an Innovative Medical Device (Technology Innovation Class) by the Ministry of Food and Drug Safety (MFDS) of Korea.
The designation, granted under the Medical Device Industry Promotion and Innovative Medical Device Support Act, recognizes cutting-edge technologies expected to significantly improve patient outcomes and generate strong industrial impact. The Technology Innovation Class focuses on areas where the development and localization of core medical device technologies are urgently needed.
iMET applies alternating electric fields at specific frequencies to selectively disrupt mitosis in rapidly dividing cancer cells while sparing normal cells that divide more slowly, thereby reducing side effects compared to conventional cancer therapies.
64-channel electrode control for precise field delivery
AI-based treatment planning system for patient-specific optimization
Multi-directional electric field focusing enabling 2–3× higher field concentration and shorter treatment times
With this designation, iMET becomes eligible for priority review of clinical trial applications and regulatory approvals, as well as full-cycle technical support and programs that accelerate market entry—expected to further speed clinical development and commercialization.
“This designation is highly meaningful as it represents a new paradigm in cancer treatment based on domestic core technologies rather than incremental improvements. We will focus our clinical studies on intractable cancers such as pancreatic cancer—where five-year survival is below 15%—to offer new treatment options for patients who do not respond to existing therapies.”
— Myung-Geun Yoon, CEO of FieldCure
Source: The Korea Economic Daily (September 25, 2025)
2025.11.03