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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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Medtronic recalls embolization device used to treat aneurysms

AuntMinnie

The recall is due to reports of a higher incidence of the flexible, braided tube part of the device failing to properly attach or stay attached to blood vessel walls during and after procedures, according to a March 18 recall notice. The FDA identified the recall as Class I, the most serious type.

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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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Gleamer acquires Pixyl, Caerus Medical

AuntMinnie

The acquisitions of the two firms add MRI to Gleamers portfolio of radiology applications covering x-ray, mammography, and CT, giving the firm a suite of AI-based tools for all core imaging modalities, the company said. Pixyl is the developer of Pixyl.Neuro, which is CE-marked and has been cleared as a Class IIa medical device by the U.S.

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