Anke Biomedical (4188-TW) announced today (20th) that it has completed a prospective study involving 1,101 participants in collaboration with National Taiwan University Hospital. The results show that among individuals identified as high-risk for obstructive sleep apnea (OSA) using the non-invasive, overnight-free smart ultrasound sleep testing system 'Anke SleepScan,' 94.8% were confirmed to have OSA after undergoing polysomnography (PSG) at a sleep center.
The study included 1,101 general health check-up participants screened at National Taiwan University Hospital. Of these, 323 were assessed as high-risk for OSA. Subsequently, 97 high-risk participants were referred to the hospital’s sleep center for overnight PSG testing, and 94.8% were diagnosed with OSA. This demonstrates that the ultrasound-based smart sleep testing system can effectively identify potential OSA patients within routine health check-ups. The research findings have recently been published in the international respiratory medicine journal *Respiratory Medicine*.
While PSG remains the gold standard for OSA diagnosis, it requires an overnight stay, which reduces patient willingness to undergo testing and makes it impractical for integration into general health screenings. In contrast, 'Anke SleepScan' offers a significant advantage: it is non-overnight, takes only about 10 minutes to complete, and enables precise pre-screening directly within health examination settings. High-risk cases can then be referred for further diagnostic confirmation and treatment.
General Manager Lee Yi-Li stated that the rapid testing capability lowers the barrier for public participation, enabling broader application in health check-ups to uncover more undiagnosed patients. This also supports the further expansion of 'Anke SleepScan' into the preventive healthcare market.
The 'Anke SleepScan' system, co-developed by Anke Biomedical and National Taiwan University Hospital, has already obtained regulatory approvals including U.S. FDA clearance, EU CE marking, and Taiwan TFDA approval, positioning it for both domestic and international commercialization.
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- Source: PR Times
- Category: Survey