Lumos Labs has obtained a clearance from the FDA for its popular Lumosity brain training platform, greenlighting a version of it to be marketed as a prescription digital therapeutic for adults with Attention – Deficit/Hyperactivity Disorder (ADHD) for the first time.
The United States Food and Drug Administration (FDA) has approved its first at-home, nondrug therapy for depression, with a wearable brain stimulation headset developed by Flow Neuroscience (Flow).
A parent’s determination leads to rare disease treatment for her son: Maxwell Freed, an 8-year-old with the extremely rare neurodevelopmental disorder known as “SLC6A1”, has become the first person in the world to receive a treatment for it, thanks to his mother, Amber Freed, who spent years fundraising and pushing Scientists and Regulators to move the research forward. While a repurposed FDA-approved drug helped buy time early on, her advocacy helped drive the creation and testing of a new gene therapy that received FDA approval in June 2025. Maxwell received the one-time treatment in September 2025 and is now in rehabilitation and showing signs of progress.
Drastic overhauls of U.S. vaccine regulations proposed by top United States (US) Food and Drug Administration (FDA) official Vinay Prasad, M.D., have drawn harsh pushback from 12 former commissioners of the Agency.
Medical device makers must comply with the U.S. Food and Drug Administration’s (FDA) Quality Management System Regulation (QMSR) after the rule took effect on Monday, 02 FEB 2026. Additionally, FDA inspections of device facilities will no longer be conducted under the prior Quality System Inspection Technique (QSIT) and instead will be carried out in accordance with a new Compliance Program Manual.
The U.S. Department of Health and Human Services (DHHS) and the U.S. Department of State announced the United States’ completion of its withdrawal from the World Health Organization (WHO) due to the organization’s mishandling of the COVID-19 pandemic that arose out of Wuhan, China, its failure to adopt urgently needed reforms, and its inability to demonstrate independence from the inappropriate political influence of WHO member states.
On 21 JAN 2026 , the U.S. Food and Drug Administration issued a Request for Information (RFI) regarding labeling and preventing cross-contact of gluten in packaged food. The FDA is taking this action as a first step to improve transparency in disclosures of ingredients that impact certain health conditions, such as gluten for those with celiac disease, and other established food allergens.
Medtech 2026: AI acceleration, regulatory changes, and economic shifts promise to reshape the industry landscape amid an innovation surge.
The Centers for Disease Control and Prevention (CDC) has updated its webpage on vaccines and autism with new claims undermining the Public Health Agency’s longtime position that vaccines do not cause the condition — garnering swift condemnation from public health advocates and the Senate’s top healthcare legislator.
Hundreds of industry leaders have signed a letter to FDA Director Marty Makary, M.D., about the importance of having a predictable Regulatory Agency (United States Food and Drug Administration – FDA), citing a survey in which 82% of biopharma respondents said they were concerned about the FDA’s ability to function.