Devices

Breakthrough Status for Cognitive Behavioral Therapy

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 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 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.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome