Devices

DeepWell Digital Software Cleared for Stress Relief

FDA has cleared a DeepWell Digital Therapeutics 510(k) for its biofeedback software development kit for use in over-the-counter treatments for reducing stress, and as an adjunctive treatment for high blood pressure when used with other pharmacological or nonpharmacological interventions. DeepWell says it will make the new technology available to media companies to embed or use in conjunction with their products, which “allows the potential to accelerate the commercialization of video games and other immersive media as FDA-cleared digital therapeutics.”

DeepWell says its software provides biostimulation in interactive media that activates the user’s vagus nerve while increasing patient engagement, which is intended to reduce sympathetic nervous system activation and release dopamine for coping that improves resilience to reduce stress and hypertension. “Immersive biofeedback-driven media increases consistent use for immediate and long-term mental and physical health benefits,” it adds.

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