Digital therapeutics company Big Health has been granted  FDA 510(k) clearance for its SleepioRx digital therapeutic aimed at reducing insomnia and improving sleep.

The 90-day SleepioRX digital treatment addresses insomnia disorder through evidence-based strategies focusing on the cognitive and behavioral aspects causing insomnia and long-term sleep issues.

The company touts that its use of cognitive-behavioral therapy (CBT) helps patients learn techniques for reshaping behaviors to quiet racing minds and resolve other sleep troubles. The platform also provides customized goal setting and a detailed sleep diary.

The app allows patients to track their progress over time, and the patient experience is customized according to individual symptoms and daily sleep monitoring. It also provides real-time support content designed to assist with falling asleep.

“The FDA’s clearance of SleepioRx is a landmark milestone for Big Health and provides accessible, guideline-recommended, first-line treatment for insomnia.” Big Health CEO Yael Berman said in a statement. “This clearance, coupled with the new proposed reimbursement codes, will for the first time motivate U.S. healthcare providers to prescribe safe and effective treatment alternatives to traditional medication.”

THE LARGER TREND

A study published in the Journal of Medical Internet Research (JMIR) in 2021  found that despite the abundance of sleep apps, there is a need for more standardized evaluations and consistent design processes due to the limited and unstandardized published literature on their effectiveness.

In 2022, Big Health secured $75 million in Series C funding, two years after garnering $39 million in a Series B raise. 

A year later, the sleep-focused company acquired prescription digital therapeutics company Limbix, provider of SparkRx,a PDTx specifically designed to help adolescents manage symptoms of depression.

Other companies with digital health platforms aimed at improving an individual’s sleep include South Korean tech giant Samsung Electronics, which introduced its One UI 5 Watch last year with a new feature that supports quality sleep.  

The Apple Watch also tracks an individual’s sleep patterns and on Tuesday Google announced the launch of its Pixel Watch 3, which tracks a wearer’s sleep and uses that data and activity data to help a user garner personal insights into recovery and training statistics.