BEACON BIOSIGNALS EXPANDS SLEEP ANALYSIS CAPABILITIES WITH FDA CLEARANCE OF SLEEPSTAGEML
BOSTON, March 27, 2024 /PRNewswire/ -- Beacon Biosignals announced today that it has received FDA 510(k) clearance for SleepStageML™️, an advanced machine learning software that automatically stages sleep from electroencephalogram (EEG) signals of clinical polysomnography (PSG) recordings to aid in the diagnosis and evaluation of sleep and sleep-related disorders. Beacon Biosignals is a health technology company focused on accelerating the development of therapies for neurological, psychiatric, and sleep disorders, and SleepStageML opens the door for more consistent, efficient, and precise sleep staging for these therapeutic areas. This latest clearance complements Beacon's previous FDA clearance of the Dreem 3S wearable headband and integrated algorithms, providing a comprehensive solution for precisely measuring sleep architecture across home and clinical settings.
- Beacon Biosignals is a health technology company focused on accelerating the development of therapies for neurological, psychiatric, and sleep disorders, and SleepStageML opens the door for more consistent, efficient, and precise sleep staging for these therapeutic areas.
- This latest clearance complements Beacon's previous FDA clearance of the Dreem 3S wearable headband and integrated algorithms, providing a comprehensive solution for precisely measuring sleep architecture across home and clinical settings.
- "With FDA clearances for both SleepStageML and Dreem 3S™ headband, Beacon now provides an unparalleled capability to measure sleep physiology whether studies are conducted in-home or in-clinic," said Jacob Donoghue, MD, PhD, CEO of Beacon Biosignals.
- This FDA clearance represents a major milestone that bolsters Beacon Biosignals' powerful machine learning platform for rapidly analyzing large neurophysiology datasets.