Devices

FDA Clears Telehealth Respiratory Wheeze Detector

FDA has cleared a TytoCare 510(k) for its Tyto Insights for Wheeze Detection, an algorithm for use on the company’s existing artificial intelligence (AI)-powered Tyto Insights smart diagnostic for telehealth use. Wheeze Detection is designed to “aid in the clinical assessment of lung sound data for adults and children aged two and above, enabling clinicians to accurately diagnose respiratory conditions remotely,” the company says. “Fueled by TytoCare’s own database of lung sounds – the largest of its kind – the AI-powered decision support software automatically analyzes lung sounds recorded by TytoCare’s FDA-cleared handheld remote exam device’s stethoscope to determine whether wheezing is detected.” During the exam, the device prompts a clinician if a specific abnormal lung sound suggestive of wheezing is suspected.

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