Neurofit Receives MFDS Class 3 Medical Device Approval for Brain Disease Treatment Electrical Stimulator 'Neurofit Ink'
[Asia Economy Reporter Hyunseok Yoo] Neurophet, an AI solution company specializing in brain disease, announced on the 27th that it has received approval from the Ministry of Food and Drug Safety (MFDS) for a class 3 medical device for the transcranial direct current stimulator (tDCS) ‘Neurophet Innk (NEUROPHET innk)’.
‘Neurophet Innk’ is a non-invasive electronic medicine that improves or treats symptoms of brain diseases such as stroke and depression through electrical stimulation. Brain disease tDCS treatment has gained attention as a treatment method because various clinical trials have verified its advantages, such as enhancing treatment effects when combined with existing treatments, being effective for patients with drug resistance, and having no serious side effects.
Neurophet has established a brain precision stimulation platform capable of designing and performing brain disease treatments by combining ‘Neurophet tES LAB (NEUROPHET tES LAB)’, Korea’s first brain imaging treatment design software medical device, with ‘Neurophet Innk’. ‘Neurophet tES LAB’ uses brain magnetic resonance imaging to reconstruct a computer brain model similar to the actual brain and then calculates the electric field distribution generated during electrical stimulation. This enables personalized treatment that precisely stimulates the target area considering the patient’s brain structure.
Neurophet plans to expand its business area to various brain disease treatment design fields such as magnetic stimulation (TMS), ultrasound, and radiation therapy, in addition to electrical stimulation.
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Kim Donghyun, Chief Technology Officer (CTO) of Neurophet, said, “Existing transcranial direct current electrode stimulation devices have the disadvantage of inconsistent treatment effects due to differences in patients’ brain structures, but by utilizing the brain precision stimulation platform combining ‘Neurophet tES LAB’ and ‘Neurophet Innk’, we expect to maximize treatment effects.” He added, “Through the brain precision stimulation platform, we will help patients suffering from brain diseases and the doctors treating them.”
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