Date 21-07-19 09:20
Heuron’s Parkinson Diagnostic Software mPDia Designated as ‘Innovative Medical Device’
The 3rd Innovative Medical Device…Developed by Heuron, A Tech Company Founded by Clinicians at Gachon University Gil Medical Center
On the 29th, Heuron announced that its medical assistive diagnostic software, mPDia has been designated as an ‘Innovative Medical Device’ by the Ministry of Food and Drug Safety.
So far, only 3 products have been designated as ‘Innovative Medical Devices’.
mPDia is regarded as the world’s first Parkinson diagnostic software and Heuron is currently carrying out clinical studies with 10 university hospitals including Seoul Asan Hospital and Seoul St. Mary's Hospital.
After getting the results from clinical trials in August, Heuron will try to get a Level 3 Medical Device approval for its software possibly in October.
Led by Donghoon Shin (CEO) who is a neurology professor at Gachon University Gil Medical Center, Heuron was founded in 2017 jointly by neurology, radiology and medical engineering professors and, Ph. D AI researchers from Gachon Medical Device Convergence Center.
Heuron is currently developing an AI software that can auto-analyze and quantify medical images (MRI, CT) of central nervous system diseases like Parkinson’s disease, stroke and dementia.
Cranial nerve diseases are a field where even the top global healthcare companies are having a hard time collecting quality data and developing solutions. Last year, we’ve received requests from two global healthcare companies wanting to collaborate with us on clinical data. We are currently trying to conduct the largest-ever clinical trials for a medical AI technology and get it approved overseas” explained Heuron.