The Food and Drug Administration (FDA) designated Wysa, Artificial Intelligence (AI) and mental health software, as an innovative device.
Wysa is a company specialized in mental health support through conversational AI techniques. It recently received a groundbreaking designation from the FDA for its Digital Health and Mental Health services, specifically involving patients diagnosed with chronic musculoskeletal pain, depression, and anxiety.
The FDA's Breakthrough Device Program is crucial to accelerating the development and approval of new medical devices and products that support the diagnosis and treatment of life-threatening diseases.
Wysa's bot has been trained to deliver cognitive behavioral therapy, which is delivered via smartphone. In addition, it has been shown to reduce symptoms of depression and anxiety, as well as improve physical function in patients with musculoskeletal conditions, as shown in a independent study published in The Journal of Medical Internet Research (JMIR).
The study aimed to compare changes in participants' mental health over two months. Results showed that patients who received digital mental health interventions as part of orthopedic care achieved improvements in pain, physical function, and depression.
“We are delighted to achieve this significant FDA designation and look forward to working closely with the Agency to continue the development of AI-based cognitive behavioral therapy,” said Jo Aggarwal, CEO and co-founder of Wysa. In addition, he explained that the company's mission is to provide various mental health options and also to do so with a platform that is always available.
