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# Curio Postpartum Depression Device Cleared
- URL: https://www.fdaweb.com/curio-postpartum-depression-device-cleared/
- Published: 2024-04-24T12:00:00.000Z
- Updated: 2026-09-14T14:29:01.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5156844

FDA has cleared a Curio Digital Therapeutics 510(k) for its MamaLift Plus, a prescription digital therapeutic for treating postpartum depression. The device is intended for use in patients 22 years of age and older, and as an adjunct to clinician‐managed outpatient care. It treats mild to moderate postpartum depression by improving a patient’s symptoms of depression, according to the company.

“MamaLift Plus delivers digital Cognitive Behavioral Therapy (CBT), Behavioral Activation Therapy (BAT), Interpersonal Therapy (IPT), and Dialectical Behavior Therapy (DBT) for postpartum depression,” Curio says. “CBT, BAT, IPT, and DBT are neurobehavioral treatments which focus on addressing the maladaptive behaviors, routines, and dysfunctional thoughts that perpetuate during postpartum depression.” It can be used on a mobile device, such as a smartphone or tablet.

The company says clearance was based on results from the Supporting Maternal Mental Health and Emotional Regulation (SuMMER), a sham-controlled randomized controlled trial involving 141 participants who had recently had a live birth and were diagnosed with PPD. The study met its primary endpoint — improvement of four or more points on the Edinburgh Postnatal Depression Scale, which is described as a clinically validated screener that is recommended by the American College of Obstetricians and Gynecologists. “In the intent-to-treat (ITT) population, 86.3% (82/95) of participants in the MamaLift Plus arm achieved a clinically meaningful improvement, versus in the sham control arm, where only 23.9% (11/46) of participants achieved a four-point improvement with a p-value <0.0001,” Curio says.