Behavioral Health Business April 26, 2024
Morgan Gonzales

In a significant milestone for the rapidly evolving, and at times tumultuous behavioral digital therapeutics (DTx) industry, the FDA granted 510(k) clearance to a novel therapeutic developed by Curio Digital.

Curio’s eight-week prescription-only digital therapeutic treats mild to moderate postpartum depression in patients ages 22 and older in tandem with clinician-supervised outpatient care.

Postpartum depression affects up to 15% of people who give birth, according to the Cleveland Clinic.

“This is an incredible development for women suffering from postpartum depression who are looking for non-pharmaceutical alternatives given the shortage of trained mental health professionals,” Dr. Alice Domar, a women’s health expert and scientific advisor to Curio, said in a statement.

Princeton, New Jersey-based Curio develops technological, behavioral health...

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Topics: Digital Health, FDA, Govt Agencies, Mental Health, Provider, Technology
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