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Senators introduce medical AI reimbursement bill

AuntMinnie

Congress aims to establish a steady reimbursement pathway for medical devices authorized by the U.S. Food and Drug Administration (FDA) that use AI and machine learning, including those used in radiology. cleared by the FDA are used in radiology. A new bill introduced in the U.S. The Health Tech Investment Act (S.

Medical 288
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FDA adds more than 120 new AI-enabled medical devices focused on radiology to list of approvals

Health Imaging

The FDA has cleared over 150 artificial intelligence- or machine learning-enabled medical devices since the beginning of August.

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FDA defines 'transparency' for AI medical devices

AuntMinnie

To that end, the group proposed a new definition of transparency based on workshop discussions with stakeholders held over the past three years, noted lead author Aubrey Shick, of the agency’s Center for Devices and Radiological Health (CDRH), and colleagues.

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How can Enterprise Imaging empower radiology in the modern health network?

AuntMinnie

While academic medical center radiology departments are expanding significantly and hospitals are adapting to health system consolidation trends, demand for innovative imaging informatics remains strong among operations and physician teams. We want to share and collaborate."

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Patient advocacy groups urge Congress to create pathway for CMS to cover AI in radiology

Radiology Business

As of Monday, the FDA has OK'd nearly 900 AI-enabled medical devices, but CMS has only assigned payment for about 10 of them.

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Patient groups call for CMS to cover AI in radiology

AuntMinnie

In a May 13 letter to representatives Kay Granger (R-TX) and Rosa DeLauro (D-CT) and senators Patty Murray (D-WA) and Susan Collins (R-ME), the groups noted that in radiology, AI is being used to help read and interpret images and help make more informed diagnoses. Food and Drug Administration has approved or cleared, the groups noted.

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ACR seeks enhancements to FDA AI risk management guidance

AuntMinnie

Food and Drug Administration (FDA) should ideally review manufacturers' plans for enabling clinical site-level validation of AI-enabled device software functions (AI-DSF), the American College of Radiology (ACR) recommended in comments on FDA's AI lifecycle management draft guidance. The full document is available at the ACR, here.