Devices

Pearl 510(k) Cleared for AI X-ray Reader

FDA has cleared a Pearl 510(k) for its Second Opinion, an artificial intelligence radiologic detection aid intended to help dentists identify numerous common dental problems, including tooth decay, calculus, and root abscesses. The device applies “computer vision” to “identify and highlight key pathologic and nonpathologic findings, including dental caries, discrepancies at the margin of existing restorations, calculus, periapical radiolucency, crowns, fillings, root canals, bridges and implants,” the company says. “When x-rays are captured in a dental office, Second Opinion immediately displays the images and any detected conditions on monitors in the operatory, giving dentists sharper vision into their patients’ oral health and giving patients greater understanding of their dentist’s findings.”

The device’s clearance was based on data from four separate clinical studies, each featuring a radiographic dataset of over 2,000 images and a reader group of 86 expert dentists and dental radiologists. “The tests showed clear advantages for readers using Second Opinion, including finding that study participants reading x-rays with the assistance of Pearl’s AI system accurately identified 36% more lesions than those without AI assistance did,” the company says.

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