Neofect Obtains MFDS Market Approval for Home Rehabilitation Smart Glove

[Asia Economy Reporter Jang Hyowon] NeoFect, a company specializing in innovative medical solutions, announced on the 6th that it has obtained market approval from the Ministry of Food and Drug Safety for its home rehabilitation product, the ‘Smart Glove’.

NeoFect was selected last June as the first case of the government’s ‘Regulatory Sandbox’ system for home rehabilitation demonstration exceptions. Subsequently, in December last year, it completed the medical device usability evaluation, and with this market approval from the Ministry of Food and Drug Safety, it can now officially launch its domestic remote rehabilitation business.

The Smart Glove, which received approval this time, is a hand rehabilitation device for home use. It includes a function that allows patients to perform rehabilitation training on their own at home while physical and occupational therapists assist patients’ training through non-face-to-face video calls. Patients conduct one-on-one remote rehabilitation training with therapists, and therapists can manage up to four patients simultaneously.

Following the Smart Glove, technical document reviews for market approval from the Ministry of Food and Drug Safety are underway for the home rehabilitation products ‘Smart Kids’ and ‘Smart Board’.

Once the business officially begins, it is expected that the utilization rate of remote rehabilitation services by patients will rapidly increase based on NeoFect’s network of over 200 rehabilitation medicine hospitals and clinics nationwide.

Rehabilitation medicine doctors and physical and occupational therapists from university hospitals, children’s rehabilitation hospitals, and rehabilitation and nursing hospitals directly participate, verifying training effects and satisfaction as stroke, spinal cord injury, and cerebral palsy patients undergo remote rehabilitation training after their initial diagnosis at the hospital.

Ban Ho-young, CEO of NeoFect, said, “Starting with this market approval, we will establish a new service model for the home rehabilitation market and work with various stakeholders to create a convenient rehabilitation treatment environment.” He added, “If the new medical service called ‘remote rehabilitation’ settles into our daily lives, innovative medical services will be provided to everyone?from the elderly and patients with mobility difficulties to patients in island regions who are in medical blind spots.”