On Sept. 4, 2025, Compumedics announced that it received FDA 510(k) clearance for Somfit-D, a single-use, home-based sleep monitoring device that records signals from a patient’s forehead.
About Somfit-D
Somfit-D is a noninvasive, single-use prescription device designed for home use in adults 21 and older who are suspected of having sleep-related breathing disorders. It serves as a diagnostic aid for the detection of sleep-related breathing disorders, sleep staging and snoring level.
The wearable device attaches to the forehead using a disposable, self-adhesive skin electrode patch. It records two frontal EEG signals along with pulse rate, SpO2, peripheral arterial tonometry (PAT), PPG, motion and snore. The system acquires data from three frontal electrodes, a tri-axial accelerometer and acoustic and plethysmographic sensors.
Somfit-D calculates and reports parameters such as PAT-derived apnea hypopnea index, obstructive desaturation index and hypnogram-derived indices including time in each sleep stage. Data are transmitted to a mobile app via Bluetooth. The device is powered by a non-rechargeable battery.
Complement to Somfit
Somfit-D complements Compumedics’ reusable Somfit, which received FDA clearance in 2023. Together, the devices create an EEG-based platform that spans both high-volume single-use and multi-night reusable diagnostic markets.
About home sleep apnea tests
HSATs are portable devices designed to monitor and record key physiological parameters such as airflow, oxygen levels and breathing patterns during sleep. These convenient diagnostic tools offer an alternative to traditional in-lab sleep studies, providing a more accessible and comfortable option for detecting sleep apnea in the convenience of one’s own home.
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