AiMIFY (1.x)
Subtle Medical, Inc.AiMIFY is a software that enhances contrast in brain MRI images after they have been taken, making lesions and other features easier for radiologists to see. It uses machine learning to improve image quality without requiring direct interaction with MRI machines, helping clinicians better identify abnormalities in the brain.
Intended Use
AiMIFY is an image processing software that can be used for image enhancement in MRI images. It can be used to increase contrast-to-noise ratio (CNR), contrast enhancement (CEP), and lesion-to-brain ratio (LBR) of enhancing tissue in brain MRI images acquired with a gadolinium-based contrast agent. It is intended to enhance MRI images acquired using standard approved dosage per the contrast agent’s instructions for use.
Technology
AiMIFY is a software as a medical device using a convolutional neural network based algorithm to enhance contrast in T1-weighted gadolinium-enhanced brain MRI images. It processes pre- and post-contrast images to produce enhanced images with improved contrast-to-noise ratio (CNR), contrast enhancement percentage (CEP), and lesion-to-brain ratio (LBR). It operates as a post-processing tool without a user interface, integrates with PACS via DICOM, and employs 2.5D UNet style neural network processing.
Performance
Performance testing included quantitative bench tests on 95 brain MRI cases showing significant improvements in CNR (average increase 559.94%), CEP, and LBR metrics compared to standard post-contrast images. Qualitative reader studies with board-certified neuro-radiologists demonstrated statistically significant improvements in lesion contrast, border delineation, and internal morphology visibility. Additional exploratory endpoints addressed vessel conspicuity, false lesion impact, lesion size validation, radiomics feature preservation, and dose appearance, all supporting safety and efficacy.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
2/1/2024
6 months - 2
FDA Approval
8/21/2024
Other devices from Subtle Medical, Inc.
- SubtleSYNTH (1.x)2024 • 510K
- SubtleMR (2.3.x)2023 • 510K
- SubtlePET2021 • 510K
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