Devices

Big Health’s SleepioRx Cleared for Sleep Help

FDA has cleared a Big Health 510(k) for its SleepioRx, a digital therapeutic intended for treating chronic insomnia/insomnia disorder as an adjunct to usual care in patients aged 18 and older. The prescription device delivers cognitive behavioral therapy — “evidence-based techniques targeting the cognitive and behavioral factors that maintain insomnia and chronic sleep problems,” the company says. Patient experience is tailored based on symptoms and daily sleep tracking. “In addition to core therapeutic components, there is in-the-moment therapeutic content for help falling asleep,” it says.

Clearance is based on data from over 25 clinical trials, which demonstrated efficacy in addressing chronic sleep issues and insomnia disorder, Big Health says. “Participants using SleepioRx have experienced up to 54% reduction in time to fall asleep, spent 62% less time awake at night, and were 45% better functioning the next day,” it says. “Follow-up data indicate that the benefits conferred by SleepioRx are long-lasting, with participants continuing to experience improvements in sleep up to three years after using SleepioRx.”

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