Digital Therapeutics Company Big Health recognized FDA 510(k) Clearance SleepioRx digital therapeutics aimed at reducing insomnia and improving sleep.
The 90-day SleepioRX digital treatment addresses insomnia disorder through evidence-based strategies that focus on the cognitive and behavioral aspects that contribute to insomnia and long-term sleep problems.
The company claims that by utilizing cognitive behavioral therapy (CBT), it can help patients learn behavior modification techniques to calm their mind and resolve other sleep disorders. The platform also offers customized goal setting and detailed sleep diaries.
The app allows patients to track their progress over time and the patient experience is tailored to their individual symptoms and daily sleep monitoring, while also providing real-time supportive content designed to help them fall asleep.
“The FDA’s approval of SleepioRx marks a milestone for Big Health, making it more accessible as a guideline-recommended first-line treatment for insomnia,” Big Health CEO Yael Berman said in a statement. “This approval and the newly proposed reimbursement code will, for the first time, encourage U.S. healthcare providers to prescribe a safe, effective alternative to traditional medications.”
Larger trends
a A study published in the Journal of Medical Internet Research (JMIR) in 2021 found that despite the abundance of sleep apps, published literature on their effectiveness is limited and non-standardized, necessitating a more standardized evaluation and consistent design process.
In 2022, Big Health will Two years after securing $39 million in Series B funding, the company raised $75 million in Series C funding.
A year later, the sleep-focused company Prescription digital therapeutics company Limbix offers SparkRx, a PDTx specifically designed to help manage depression symptoms in adolescents.
Other companies offering digital health platforms aimed at improving individual sleep include: South Korean tech giant Samsung Electronics unveiled its One UI 5 watch last year with new features aimed at helping people get a better night’s sleep.
of The Apple Watch also tracks personal sleep patterns, and Google on Tuesday announced the launch of the Pixel Watch 3, which tracks the wearer’s sleep and uses that data, along with activity data, to help users get personalized insights into their recovery and training stats.
