Devices

Akili OTC App Cleared for ADHD

FDA has cleared an Akili 510(k) for EndeavorOTC (AKL-T01) as an over-the-counter treatment for adults with attention-deficit/hyperactivity disorder (ADHD). Delivered through a video game experience, EndeavorOTC is intended to improve attention function as measured by computer-based testing in men and women with primarily inattentive or combined-type ADHD. It is currently available on the Apple App Store for iOS and the Google Play Store for Android mobile devices.

Clearance was based on data from a clinical study of 221 adults with a verified diagnosis of inattentive or combined-type ADHD who all received EndeavorOTC for six weeks, according to the company. “Overall, 83% of study participants reported improvement in focus as measured by the TOVA attentional control score,” it says. “Nearly three-quarters (72.5%) of participants reported at least some improvement in their quality of life as measured by the validated Adult ADHD Quality of Life Scale (AAQoL), and nearly 50% (45.8%) of adults met a prespecified threshold for clinically meaningful improvement. In the same study, adults using AKL-T01 also showed significant improvement in clinician-rated ADHD symptoms, as measured by the Attention Deficit Hyperactive Disorder Rating Scale-5 (ADHD-RS) inattention subscale and total scale scores (p<0.0001 for both).”

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