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The Rise of AI in Medical Devices: What It Means for Hiring and Innovation

MRI Network

The number of machine learning- and AI-powered medical devices approved by the U.S. In 2024, the FDA approved nearly 1,000 AI medical devices compared to just 221 in 2023. At the same time, there are concerns about whether the FDA has approved some medical devices too quickly.

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

AuntMinnie

With strong demand for medical imaging in many differing clinical contexts, hospitals are managing growing routine imaging demands while balancing teaching practices, ambulatory services, primary care, and subspecialty services. billion healthcare facility. Another, a new hospital complex is underway at University of Utah Health.

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FDA analysis affirms use of computational models in imaging trials

AuntMinnie

In silico imaging trials represent a viable source of regulatory evidence for imaging device evaluation, according to an analysis conducted by the U.S. Food and Drug Administration (FDA) and published August 9 in Plos Computational Biology. Read the full paper here.

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Commercial AI devices lack clinical validation, study finds

AuntMinnie

Commercial AI devices that lack adequate clinical validation may pose risks for patient care – and unfortunately, that’s true for almost half of the tools cleared so far by the U.S. Most notably, 226 of 521 (43%) lacked published clinical validation data.

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Median highlights clinical trial results for eyonis LCS

AuntMinnie

French imaging software developer Median Technologies is highlighting results from the RELIVE clinical trial regarding its AI-based CADe/CADx software as a medical device for lung cancer screening, eyonis LCS.

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Large language models underperform in breast imaging

AuntMinnie

Simply put, we cannot use large language models as a medical device,” Cozzi told AuntMinnie.com. The researchers also assessed the impact of discordant category assignments on clinical management. Frequency of BI-RADS category changes in clinical management of breast imaging findings Finding Human readers Gemini GPT-3.5

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ACR responds to Congressional query on AI reimbursement

AuntMinnie

MD, issued a nine-page letter to Congress recommending how to solve the reimbursement problem for AI in healthcare and ensure clinical AI is of value to patients and health systems. American College of Radiology (ACR) CEO William Thorwarth Jr.,