Devices

EnsoData 510(k) for Sleep Apnea Device

FDA has cleared an EnsoData 510(k) for new capabilities and enhancements to its EnsoSleep product, an artificial intelligence-assisted sleep scoring program that automates event detection in polysomnography (PSG) and home sleep apnea tests (HSAT). “Our enhancements to EnsoSleep will help to further expand patient access to quality care at home and improve the depth and breadth of sleep data available today, while also laying the foundation for the future, with our growing provider and technology partner ecosystem, to provide more accurate wearable health tracking to consumers down the line,” the company says.

Updates authorized under the 510(k) include:

a Sleep/Neuro AI device for pediatrics (ages 13 and up) to help clinicians diagnose sleep apnea in adolescent and teen patients, which if left untreated, has been associated with poor cognitive and school performance, as well as psychiatric and behavioral problems
Interoperable viewing software that provides interoperable PSG/HSAT data viewing, editing, and reporting tool, and
New event types for chronic respiratory and cardiac patients. The new update introduces additional sleep apnea subtyping and detection capabilities, including Cheyne-Stokes respiration, periodic breathing episodes, and respiratory rate.

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