SleepCogni has completed the medical device registration process with the US FDA as a Class II Biofeedback Device.
Registration with the FDA enables immediate access to the US market and its estimated 70m sleep sufferers. According to the Centres for Disease Control and Prevention (CDC), one in three people suffer with insomnia at some point in their lives.
SleepCogni’s patented biofeedback device measures physiological, behavioural and environmental parameters and provides direct and personalised feedback to help patients take control of their wind down process before sleep, allowing them to relax and reduce their insomnia.
This is a significant milestone in SleepCogni’s overall goal to commercialise, offering our services to sleep clinicians and cognitive behavioural therapists. SleepCogni’s medical device innovatively provides users with an immediate sleep aid whilst simultaneously collecting data to provide informed insight for clinical intervention, including CBT-I, to optimise their sleep quality.
Dr Maan van de Werken said:
“We are pleased to complete registration of our device with the FDA as a medical device. This is a major milestone in our regulatory and clinical pathway. Now that we have recently received highly encouraging preliminary results on SleepCogni’s effectiveness to treat insomnia, registration with the FDA will allow us to start rolling our product out to insomniacs through their sleep clinicians or CBT-I therapists.
We will work with a number of already committed sleep clinicians to roll out our product ahead of opening up to the wider sleep clinic community. By working with these key sleep clinics gather additional data on effectiveness of SleepCogni to treat insomnia and enhance and streamline the clinician-patient relationship.”
SleepCogni’s FDA registration was funded and supported by the Advanced Wellbeing Research Centre Accelerator Program at Sheffield Hallam University. Dr Donn Ponser is the SleepCogni US legal entity.