Devices

FDA Clears Rx Digital Therapeutic for Adult ADHD

FDA has cleared a Lumos Labs 510(k) for LumosityRx, a prescription digital therapeutic intended to improve attention in adults (ages 22 to 55) with attention-deficit/hyperactivity disorder. The mobile app adapts 13 cognitive training games into a regulated therapeutic module designed to target cognitive processes tied to attention. Lumos Labs, which operates the widely used Lumosity brain training platform, said the authorization marks a significant expansion of its business into clinical-grade digital medicine.

The clearance is based on data from the pivotal GAMES Study, a randomized, double-blind, sham-controlled trial enrolling more than 500 adults across 13 U.S. sites, according to the company. Participants using LumosityRx demonstrated statistically significant improvement on the Test of Variables of Attention (TOVA), the trial’s primary objective endpoint, compared with a control app. According to the company, 44.2% of treated participants achieved clinically meaningful gains in attention, defined as improvements of more than 1.4 points on the TOVA Attention Comparison Score.

Lumos Labs say the product is intended to be used alongside clinician-directed therapy, medication, and educational programs, noting that improvements are specific to sustained and selective attention and may not extend to behavioral symptoms such as hyperactivity. The company also cautioned that the software may not be suitable for individuals with photosensitive epilepsy, color blindness, or physical limitations affecting mobile device use.

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