The new Sleep Watch actigraph features cloud-based software and over-the-air updates, offering sleep estimation for children and adults.
Key takeaways:
- The Sleep Watch received FDA 510(k) clearance as a class II biofeedback device for sleep assessment.
- It features a smart watch design with sensors including an accelerometer, gyroscope, PPG, and light and temperature sensors.
- The initial release will be in actigraphy only mode and priced at $995, with a $600 annual cloud license.
- The device is indicated for prescription use in children and older patients to estimate sleep quantity and quality.
Ambulatory Monitoring Inc (AMI) will soon release a new smartwatch-style actigraph named Sleep Watch, which is designed to monitor activity and estimate sleep parameters. The device received 510(k) clearance from the US Food and Drug Administration (FDA) in July 2025.
The Sleep Watch is designed to document physical movement associated with physiological monitoring. “AMI is excited to announce the upcoming release of its new smart watch style actigraph, called Sleep Watch, with accuracy and reliability in the Motionlogger tradition,” says Thomas Kazlausky, president of AMI. The initial release of the device will function in “actigraphy only” mode to comply with the current FDA clearance.
The system utilizes cloud-based software and supports over-the-air updates, which AMI states will allow for the introduction of new features as they receive FDA approval.
Device Specifications and Technology
The Sleep Watch is a wrist-worn device equipped with multiple sensors, including an accelerometer, gyroscope, photoplethysmogram, skin temperature sensor, and light sensor. It also incorporates Bluetooth Low Energy and Wi-Fi connectivity.
It uses proprietary algorithms to analyze actigraphy data—specifically accelerometry—to estimate sleep/wake states, sleep latency, sleep duration, and sleep quality. It allows for the analysis of circadian rhythms and includes a psychomotor vigilance task feature.
Data collected by the Sleep Watch is transmitted to a software-as-a-service platform for remote review by clinicians. The system provides graphical and numerical reports intended for use by physicians, trained technicians, and other healthcare professionals to aid in the evaluation of sleep disorders.
Indications and Pricing
The Sleep Watch is a prescription-use device indicated for use in the home environment for patients classified as children and older. It does not provide physiological alarms.
According to the company, the price for the first release is $995. The accompanying cloud license is priced at $600 per device, per year.
The FDA clearance classifies the Sleep Watch under regulation number 21 CFR 882.5050 as a biofeedback device (product code LEL). The FDA determined the device is substantially equivalent to legally marketed predicate devices, noting that it raises no new questions of safety or effectiveness.
