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AI-based medical software: how will the FDA deal with it?

The FDA announced that they will be investigating a new review framework for AI-based medical devices. Over the past few years the FDA actually cleared many AI-based software programs. What is the difference between these types of AI algorithms and the ones referred to by the FDA? Why can the latter not be handled by current review frameworks?

Quantib - How will the FDA dealt with artificial intelligence based medical software

QUANTIB™ ND

Your indispensable tool for atrophy quantification and WMH detection

Quantib™ Neurodegenerative provides quantification and segmentation of MRI brain scans. The radiology software allows you to create and display self-defined views including an overlay of segmented brain structures and white matter hyperintensities. You can easily download and share a comprehensive report including quantified results of follow-up analysis of brain atrophy and WMH development.

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We push advanced technology forward to make sure radiologists can spend their time in the best way possible. Our engineers go to great lengths to create user-friendly radiology software solutions for challenging image analyses issues.

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WHITEPAPER

QuantibTM Brain

QuantibTM Brain provides white matter hyperintensity and brain tissue quantification. It offers a tool to objectively assess brain changes in longitudinal exams in neurodegenerative disease.

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SAMPLE REPORT

Sample Report

QuantibTM Brain Report

QuantibTM Brain allows you to download the examination results in a comprehensive report including self-selected cross-sections and personal comments.

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AI-based medical software: how will the FDA deal with it?

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