Well done for launching! I'm just very conscious of over-claiming and pseudoscience in this space... Is this classed as a medical device / SaMD? Does it requir

Well done for launching! I'm just very conscious of over-claiming and pseudoscience in this space... Is this classed as a medical device / SaMD? Does it require FDA / MHRA approval or CE marking? Why is there information on your website about Fatal Familial Insomnia when it is vanishingly rare and has only been reported a few dozen times worldwide? Are those self-reported improvements in sleep and can you measure more objectively with polysomnography? In the UK there's an app called Sleepio which is NICE-approved and prescribed to patients - is your app similar? One last question - how did you come up with the pricing ($63 per month)?