Swing Therapeutics app Stanza receives FDA’s De Novo this week

Stanza app received FDA de Novo

Swing Therapeutics app Stanza received FDA’s De Novo clearance last week. 

Stanza provides Acceptance and Commitment Therapy (ACT), a form of Cognitive Behavioral Therapy (CBT) intended to improve the psychological symptoms associated with fibromyalgia, including anxiety, depression, and sleeplessness, in adult patients.

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About Swing Therapeutics’ app Stanza 

Developed with leading fibromyalgia experts, clinicians, and people who have fibromyalgia, Stanza is tailored to the unique experiences of living with fibromyalgia.

Fibromyalgia is a chronic, widespread pain condition that affects about 10 million people in the U.S.

In addition to experiencing chronic pain, people with fibromyalgia can be challenged by fatigue, difficulty sleeping, reduced daily functioning, difficulty concentrating (“brain fog”), and the mental and emotional health challenges that naturally can arise from these symptoms.Stanza App FDA Approval

The digital health app encompasses several modules that work together to assist the user. It has a rich set of lessons that help users practice new ACT skills to help manage symptoms.

There is a section on Mindfulness activities that help users manage their stress. Beyond the core ACT component, the app also has a section that serves as a journal and integrates with Reminders.

According to the company, Stanza is designed to be used five to seven days per week, for approximately 15 to 20 minutes a day, over a 12-week period. After 12 weeks, the application can be used as needed.

The app is available both in the iOS store as well as the Android store. 

The exciting development around digital therapeutics comes at a time when the industry is experiencing significant changes. Last month, Pear Therapeutics, a leader in digital health, said that it is filing for bankruptcy.

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Sudz Niel Kar
I am a technologist with years of experience with Apple and wearOS products, have a BS in Computer Science and an MBA specializing in emerging tech, and owned the popular site AppleToolBox. In my day job, I advise Fortune 500 companies with their digital transformation strategies and also consult with numerous digital health startups in an advisory capacity. I'm VERY interested in exploring the digital health and fitness-tech evolution and keeping a close eye on patents, FDA approvals, strategic partnerships, and developments happening in the wearables and digital health sector. When I'm not writing or presenting, I run with my Apple Watch Ultra or Samsung Galaxy Watch and closely monitor my HRV and other recovery metrics.


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