- Beacon Biosignals received U.S. Food and Drug Administration clearance for its sleep monitoring headband.
- Beacon’s at-home device, the Dreem 3S, features six electroencephalogram (EEG) electrodes to capture brain activity and a 3D sensor to monitor head movement in the night.
- The FDA granted the 510(k) clearance after concluding Dreem 3S is substantially equivalent to the Nox Sleep System, a rival device that can capture a wider range of data but requires users to attach sensors and wear a recorder on their chest while sleeping.
Traditionally, physicians and clinical trial investigators have asked patients to spend a night at a sleep lab to capture data on their nighttime physiology. Technological advances have allowed physicians to capture sleep data at home and without tethering patients to the bed.
Beacon’s newly cleared Dreem 3S builds on the earlier breakthroughs by consolidating the sensors and other technology needed to capture certain sleep data into a headband. The device is designed to collect the same data as sleep and activity studies while minimizing the impact on patients.
“It is very important patients suffering from disturbed nighttime sleep be accurately monitored in their natural settings. This new solution makes that possible and has potential to help further research and therapeutic interventions within the field,” Maurizio Fava, psychiatrist-in-chief at Massachusetts General Hospital and member of Beacon’s scientific advisory board, said in a statement.
The device, which Beacon is pitching at clinical trial sponsors, is entering a sleep market with multiple incumbent products. Beacon cited Nox Medical’s sleep system, which is distributed by ResMed in some markets, as the predicate device. Nox cited another competitor, Compumedics, in its 510(k) filing.
All the devices capture evidence of sleep but there are differences in the data they collect and the ways they connect to patients. The Nox system has additional inputs beyond EEG, allowing the collection of a wider range of data, but has a different form than Dreem 3S.