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# Breakthrough Status for Cognitive Behavioral Therapy
- URL: https://www.fdaweb.com/breakthrough-status-for-cognitive-behavioral-therapy/
- Published: 2024-02-22T12:00:00.000Z
- Updated: 2026-09-14T14:23:41.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5156413

FDA has granted Better Therapeutics a breakthrough device designation for its Cognitive Behavioral Therapy (CBT) platform that is intended to treat adults with metabolic dysfunction-associated steatohepatitis (MASH). The designation is based on data from the company’s LivVita clinical study, which met its primary endpoint by reducing liver fat within 90 days, while also achieving key secondary endpoints related to improved liver health without any device-related adverse events, Better Therapeutics says. Results of the study were recently [published](https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.ghadvances.org%2Farticle%2FS2772-5723%252823%252900143-7%2Ffulltext&esheet=53898255&newsitemid=20240220610918&lan=en-US&anchor=published&index=2&md5=dbaf46abc12d7feacf1d5c802e4dd120&ref=fdaweb.com) in *Gastro Hep Advances.*

The company says its CBT works by targeting the lifestyle behaviors that are known to cause and/or contribute to the progression of metabolic diseases. “The platform was developed to address the current gap in broadly accessible and standardized intensive behavioral therapies that effectively enable the implementation of existing treatment guidelines that call for behavior change as the foundation of treatment,” it says, adding that the platform has already demonstrated clinically meaningful outcomes in Type 2 diabetes, leading to the FDA de novo authorization of [AspyreRx](https://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.aspyrerx.com&esheet=53898255&newsitemid=20240220610918&lan=en-US&anchor=AspyreRx&index=4&md5=47a1f406e6d7e76adcdb3275634cd800&ref=fdaweb.com) in 2023 as the first prescription digital therapy to deliver such therapy for diabetes.

MASH is described as an advanced stage of metabolic dysfunction-associated steatotic liver disease, a condition tied to the increasing obesity and diabetes epidemics.