Devices

Darmiyan De Novo for Alzheimer’s Assessor

FDA has granted Darmiyan a de novo marketing authorization for its clinical test BrainSee. The software platform combines standard clinical brain MRI and cognitive assessments to generate an objective score that predicts the likelihood of progression from amnestic mild cognitive (aMCI) impairment to Alzheimer's dementia within five years. The company says the device uses its patented core proprietary technology that is based on 40 years of “cutting-edge brain science, powered by advanced whole-brain image analysis and medical AI.”

Darmiyan says that early screening and risk stratification by BrainSee “enables timely and personalized treatments for those aMCI patients at high risk of progression to Alzheimer's dementia, aiming to delay dementia onset, while reassuring those at lower risk of progression, hence reducing the need for costly and invasive tests and the heavy burdens of financial and emotional abuse.”

BrainSee was previously granted an FDA breakthrough designation in 2021.

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