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FDA Issues Final Guidance For Radiological Devices Using Quantitative Imaging

Document updates agency’s 2019 guidance

 
• By Brian Bossetta

The US FDA has published its final guidance for premarket submissions of radiological devices that use quantitative imaging – technology which offers clinicians a more accurate picture of a disease.

Doctor Scanning MRIs
• Source: Shutterstock

After publishing an initial guidance on the topic three years ago, the Food and Drug Administration has issued its final guidance for manufacturers submitting radiological devices that use quantitative imaging for premarket review.

The document, “Technical Performance Assessment of Quantitative Imaging in Radiological Device Premarket Submission,” posted on 16 June, clarifies that manufacturers submitting these devices to the agency should provide performance...

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