Devices

TytoCare Get Clearance for AI Lung Sound Device

FDA has cleared a TytoCare 510(k) for its Tyto Insights for Rhonchi Detection, an artificial intelligence (AI)-based device for detecting, during a virtual exam, all three major abnormal lung sounds — wheezes, crackles, and rhonchi. The company says the the diagnosis of these abnormal lung sounds presents a recognized challenge for trained medical professionals. “By combining smart digital stethoscope technology with AI that identifies key lung sound abnormalities, TytoCare enables providers to deliver faster, more accurate diagnoses, while patients will get timely, high-quality care from the comfort of their homes, reducing unnecessary clinic visits and improving health outcomes through earlier detection and intervention,” the company says.

The AI device is built on TytoCare’s proprietary database of 1.8 million lung sound recordings and leverages machine-learning algorithms trained and validated by pulmonologists, the company says. “Clinical validation demonstrated that the device performs equivalently to, or better than, non-pulmonologist clinicians — confirming that the algorithm is a powerful and reliable detector…,” it says, adding that the algorithm demonstrated “strong discriminative ability across all three sound types.”

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

Read more

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