Devices

De Novo Granted for Autism Diagnosis Aid

FDA has granted a de novo marketing authorization request to Cognoa for its Cognoa ASD Diagnosis Aid to help diagnose autism spectrum disorder (ASD). The machine learning-based software is intended to help health care providers diagnose ASD in children 18 months through five years of age who exhibit potential symptoms of the disorder.

“Because ASD symptoms can vary greatly, the disorder may be difficult to diagnose,” an FDA release says. The device uses a machine learning algorithm to receive input from parents or caregivers, video analysts and health care providers to assist physicians evaluate a patient’s ASD risk, it says. It comprises three main components: a mobile app for caregivers and parents to answer questions about behavior problems and to upload videos of their child; a video analysis portal that allows manufacturer-trained and certified specialists to view and analyze uploaded videos of patients; and a health care provider portal that is intended for a health care provider to enter answers to pre-loaded questions about behavior problems, track the information provided by parents or caregivers and review a report of the results.

FDA says that after processing information provided by parents, caregivers and healthcare providers, the device reports a positive or negative diagnosis if there is sufficient information for its algorithm to make a diagnosis. If there is insufficient information, it will report that no result can be generated.

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