Healthcare Innovation by clinical AI
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 28th,
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.