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Bell Therapeutics Obtains GMP Certification for Medical Device Software Manufacturing

Aug 8, 2024

MONEY TODAY | Jun-young Ryu

The neuroscience-based digital therapeutics startup Bell Therapeutics announced on the 8th that it has received a Good Manufacturing Practice (GMP) certification from the Ministry of Food and Drug Safety for meeting medical device manufacturing and quality management standards.


The MFDS GMP certification is awarded to companies that strictly comply with manufacturing processes and quality control standards to ensure the quality of pharmaceuticals and medical devices.


Bell Therapeutics is focused on treating diseases through brain science and audio signal processing technology, accelerating the development of digital therapeutics for insomnia and cochlear implant hearing rehabilitation.


The GMP-certified insomnia digital therapeutic from Bell Therapeutics provides sound stimulation optimized for the patient's autonomic nervous system to improve insomnia symptoms. Based on this certification, Bell Therapeutics plans to initiate a clinical trial authorized by the Ministry of Food and Drug Safety for insomnia patients in Korea.


CEO Jae-eun Lee stated, "Bell's digital therapeutic, designed with a unique mechanism distinct from existing insomnia DTx, aims to demonstrate new possibilities in digital treatment." He added, "Starting with the GMP certification, we plan to pursue designation as an innovative medical device within the year, along with FDA 510(k) clearance and international clinical trials."

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