Asleep announced Friday that its smartphone-based digital medical device for sleep apnea, Apnotrack, has obtained CE MDR certification under the European Union's Medical Device Regulation.
Apnotrack is a software medical device that screens for moderate-to-severe sleep apnea risk using a smartphone. The certification provides Asleep with the regulatory foundation to enter the European consumer market. CE MDR is the medical device regulation that must be met to sell medical devices in the European market. Apnotrack obtained CE marking as an EU MDR Class I software medical device.
Apnotrack is a portable software medical device that collects breathing sounds during sleep through a smartphone microphone, with an artificial intelligence (AI) algorithm recording and analyzing breathing patterns such as apnea and hypopnea. A key feature is that users can screen for sleep apnea using only a smartphone, without separately wearing a wearable device equipped with an accelerometer or blood oxygen saturation (SpO2) sensor.
Performance metrics were also presented. Apnotrack recorded sensitivity of 87% and specificity of 92% in identifying moderate-to-severe sleep apnea (AHI 15 or higher). Sensitivity is an indicator showing the ability to screen actual at-risk groups without missing them, and is one of the key criteria for assessing the viability of early screening tools. Asleep said Apnotrack demonstrated competitiveness in sensitivity when compared with the publicly disclosed performance metrics of the Apple Watch sleep apnea feature, which uses the same moderate-to-severe evaluation standard. The Apple Watch sleep apnea feature's publicly disclosed performance shows overall weighted sensitivity of 66.3% and specificity of 98.5%.
Asleep plans to first target the over-the-counter (OTC) channel in Europe, where consumers use the product directly. With access to diagnostic infrastructure such as polysomnography being relatively limited in Europe, the company expects Apnotrack — which can be used with just a smartphone and no additional devices — to address general consumer demand for self-screening of sleep apnea. Clinical validation data accumulated in Korea is also expected to support the product's credibility in the European consumer market.
Based on this CE MDR certification, Asleep is now able to supply Apnotrack to consumer markets in 30 countries within the European Economic Area (EEA), including the 27 EU member states. The company plans to use this as a stepping stone to accelerate its global market expansion.
"We will accelerate our entry into the OTC market so that European consumers can easily detect sleep health issues at an early stage," said Lee Dong-heon, CEO of Asleep.
