Ministry of Food and Drug Safety Designates an Assistive Diagnostic Device and Assistive Surgical Device as Innovative Medical Devices…Four Devices Have Been Designated as Innovative Medical Devices So Far

On the 28^th, the Ministry of Food and Drug Safety announced that is has designated a ‘medical assistive diagnostic software for Parkinson’s disease’ and a ‘frameless stereotaxic navigation system for breast surgeries’ as ‘Innovative Medical Devices’.

The ‘medical assistive diagnostic software for Parkinson’s disease’ is a software Heuron is currently developing using an AI technology. Unlike conventional diagnostics that use PET-CT scans, Heuron’s software assists the clinicians in making diagnosis by analyzing MR images and determining abnormalities in the damaged brain regions. The software has been recognized for its original diagnostic technology.

The ‘frameless stereotaxic navigation system’ currently being developed by Skia is an assistive product that fixates and guides the position of surgical tools. The system will assist breast surgeries by using a AR technology to show the location of breast tumors. The AR technology recreates 3D images by combining CT images and actual images of the body of a breast cancer patient. This is intended to help clinicians better determine the area of a tumor that needs to be removed. 

‘Innovative Medical Devices’ are medical devices that use advanced technologies like ICTs, biotechnologies and nanotechnologies and that are or expected to be safer and more effective than existing medical devices or therapies. The Minister of Food and Drug Safety designates them according to the Act on the Promotion of the Medical Device Industry and Support for Innovative Medical Devices’. Medical devices designated as Innovative Medical Devices can be evaluated prior to other medical devices or receive an expedited evaluation depending on their developmental stage.   

Two medical devices (‘medical assistive diagnostic software for Parkinson’s disease’ and ‘medical neutron radiation therapy system’) have been designated as Innovative Medical Devices on July 22 and so far, a total of 4 medical devices have been designated as Innovative Medical Devices.