Beacon Biosignals wins FDA nod for wearable sleep monitor

The Dreem 3S. [Image courtesy of Beacon Biosignals]Beacon Biosignals announced today that it received FDA 510(k) clearance for its Dreem 3S wearable electroencephalogram (EEG) headband.

The Boston-based company developed Dreem 3S with integrated machine learning algorithms. The advanced wearable headband captures EEG data from the brain to monitor sleep architecture and aid in diagnosing disturbed sleep.

Beacon Biosignals says its easy-to-use device makes it simple for patients to participate in clinically validated EEG-based sleep monitoring. By using it at home, patients can unlock new insights into sleep physiology. The company acquired the platform by buying the R&D business of Dreem in July.

Traditional research for these types of therapies requires patients to spend nights in sleep laboratories or use less-precise wrist actigraphy. Dreem 3S — the first dry-EEG medical device of its kind — allows for convenient data collection at home. Patients use…

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How EEG data and machine learning can inform drug development

EEG data can bolster rare disease drug research and trials. An epilepsy drug trial, for instance, could ask patients to log the number of seizures they experience in a day. “If you look at a seizure diary, there might be 10 seizures a day. But if you look at EEG, there could be 150,” said Dr. Jacob Donoghue, a neurologist, neuroscientist and CEO of Beacon Biosignals.

EEG data can thus help improve the treatment of epilepsy by uncovering hidden patterns in patients’ brains. Such data also holds promise for testing experimental drugs for sleep disorders and neurodegenerative conditions such as Alzheimer’s disease, Donoghue said in a recent interview.

In the following Q&A, Donoghue explains how EEG data — paired with machine learning — can inform clinical trials and how such data can make the fields of neurology and neuroscience more objective.

The responses have been lightly edited.

Drug Discovery & Development (DDD):…

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