*Works with most commercially available mattresses **This feature is a non-medical function and these statements have not been reviewed and approved by the FDA. The Sleep Summary feature presented on this website as well as the associated information is not intended to be used for treatment or diagnosis and the product has not been assessed by the FDA for this reason. For non-diagnostic use only. This device is being made available by  FDA Emergency Use Authorization (EUA) Guidance published by FDA and is supported by the Secretary of Health and Human Service’s (HHS’s) declaration that circumstances exist to justify the emergency use of medical devices, including alternative devices used as medical devices, due to shortages during the COVID-19 outbreak. The monitoring information provided by the device are adjunctive (supporting) and should not be solely or primarily relied upon to prevent, diagnose, or treat COVID-19 or co-existing conditions.EarlySense InSight is an FDA cleared device that has been modified as ‘InSight at Home’, to allow for home use under an EUA guidance published by the FDA. Some of the changes such as the sleep summary and home use function have not undergone the same type of review as an FDA-cleared device.