Consumer sleep technology (CST) broadly includes wearables, nearables (e.g., radio- and sonar-based smart systems, under the mattress system), and mobile stand-alone applications1 designed to be directly used by consumers. Most CST falls within the area of “wellness products”, which are not approved by the US Food & Drug Administration (FDA). This could soon change due to potential upcoming regulatory changes in digital health (e.g., “The Software Precertification (Pre-Cert) Pilot Program”, https://www.fda.gov/medical-devices/digital-health-center-excellence/digital-health-software-precertification-pre-cert-program). However, systematic use of CST as a substitute for accepted methods of sleep tracking in the diagnosis and management of sleep disorders, is currently discouraged (Khosla et al., 2018).
Performance of consumer wearable sleep technology
Menghini, Luca;
2021
Abstract
Consumer sleep technology (CST) broadly includes wearables, nearables (e.g., radio- and sonar-based smart systems, under the mattress system), and mobile stand-alone applications1 designed to be directly used by consumers. Most CST falls within the area of “wellness products”, which are not approved by the US Food & Drug Administration (FDA). This could soon change due to potential upcoming regulatory changes in digital health (e.g., “The Software Precertification (Pre-Cert) Pilot Program”, https://www.fda.gov/medical-devices/digital-health-center-excellence/digital-health-software-precertification-pre-cert-program). However, systematic use of CST as a substitute for accepted methods of sleep tracking in the diagnosis and management of sleep disorders, is currently discouraged (Khosla et al., 2018).I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.