Digital healthcare startup Bell Therapeutics announced on the 23rd that its insomnia digital therapeutic 'Sleep Thera' has been designated as an innovative medical device (advanced technology category) by the Ministry of Food and Drug Safety. This achievement comes just two years after the company's establishment.
Sleep Thera is a novel medical device that treats insomnia by generating personalized digital stimuli based on biometric signals. Once designated as an innovative medical device, it can receive priority review from the Ministry of Food and Drug Safety. This allows it to be sold in the medical field for 3 to 5 years either as a non-reimbursable or selectively reimbursable service after market entry.
Meanwhile, the technology and clinical results of Sleep Thera were presented at the SLEEP conference held in the United States in June this year.