▲ Professor Hangsik Shin from the Department of Convergence Medicine

The Home Sleep Apnea Testing (HSAT) devices offer patients the convenience of monitoring their sleep at home. However, clinical reliability has been limited due to the lack of standardized verification procedures for device performance and safety.

A research team led by Professor Hangsik Shin from the Department of Convergence Medicine at Asan Medical Center recently published a study analyzing the FDA approval process and clinical efficacy of HSAT, providing standards for the safe development and commercialization of HSAT. The analysis of HSAT devices approved by the FDA from 2003 to 2023 revealed that Type-3 devices were most commonly used, with most devices complying with electrical safety and biocompatibility standards. Through this, the study highlighted the need for clinical trials to ensure device safety and the development of guidelines to ensure clinical efficacy.

The study findings were recently published in ‘npj Digital Medicine,’ an international academic journal.