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SleepCogni is now registered for medical use by the Food and Drug Administration (FDA). The device is data-supported, targeting those who suffer from insomnia, and aims to break cognitive cycles that prevent sleep. Preliminary analysis shows that the device does, in fact, reduce insomnia (as measured by Insomnia Severity Index) within seven days of use through the hand-held sleeping aid that allows users to self-manage their insomnia. The device has cleared FDA device registration.
Founded in 2015, SleepCogni co-founders Richard Mills, Sheffield-based entrepreneur, and Dr. Maan van de Werken, Dutch chronobiologist (sleep expert), have raised 1.8 million euros (roughly 2.2 million US dollars) for technology development, including the investments of Mercia, a private venture capitalist source, and three research and development grants through Innovate UK, the official innovation agency of the UK.
The device has received eleven patents, including ones for the Active-Biofeedback technology that uses haptic feedback to help break destructive sleep patterns.
The company will soon begin beta testing at two of its locations in the United States, including one located at a pronounced healthcare system. After testing, the devices will be rolled out to 130 clinics of the country’s largest sleep care management group.
“FDA registration is a major development for the company, giving us access into the American market where, according to the Centres for Disease Control and Prevention, one in three people suffer from insomnia at some point in their lives. This coincides with an agreement to roll out our device in 130 US sleep clinics following the successful completion of its final testing, “says Mills.
The FDA oversees devices such as these for potential use in the United States upon successful testing. If you have questions about FDA registrations, including FDA food registration for facilities, please contact us at 786.442.2543.