Devices

How Will FDA Regulate ‘Vision Language Models’?

Mosaic Clinical Technologies is petitioning FDA to clarify the regulatory status of commercially available artificial intelligence vision language models (VLMs). The petition says VLMs perform medical image analysis to support diagnosis and treatment and ensure consistent application of medical device requirements to these tools. “The safety and effectiveness of these tools are of utmost importance to patient safety and ensuring clinically meaningful and reliable diagnostic outcomes for patients,” Mosaic says.

The petition cautions that as the technologies are increasingly commercialized and deployed in clinical settings, differing interpretations have emerged about the application of existing FDA medical device requirements, creating uncertainty for developers, healthcare organizations, clinicians, and patients.

“Clarity on standards will ultimately accelerate both the development and adoption of safe and trusted clinical diagnostic technologies,” Mosaic says. “This petition seeks clarification regarding how existing statutory and regulatory principles should be applied consistently to commercially distributed diagnostic imaging VLMs and related technologies.”

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