Press release

Microstructure Imaging Receives FDA Clearance for MICSI-RMT, Bringing Random Matrix Theory Denoising Into Clinical Practice

businesswire,
0
Sponsored by Businesswire

Microstructure Imaging, Inc. (MICSI), a YCombinator backed, NYU Langone Health spinout, is thrilled to announce FDA 510k clearance for its MICSI-RMT software suite, designed to enhance MRI image quality. This clearance marks the clinical translation of advanced MRI research led by Gregory Lemberskiy, CEO, and Benjamin Ades-aron, CTO.

MICSI-RMT employs a random matrix theory-based algorithm to significantly improve MRI image quality through the redundancy of the MRI exam. Unlike traditional AI methods, MICSI-RMT achieves these remarkable results without the need for external training data or high-performance GPUs. Additionally, MICSI-RMT includes processing modules that support weighted linear least squares and Bayesian fitting techniques to facilitate quantitative analysis of diffusion weighted imaging. Lastly, MICSI-RMT features cutting edge DICOM data routing ensuring securing and seamless integration into medical workflows.

Key Insights from the Clinical Study:

  • Improved Image Quality: In a randomized, blinded rater study, expert neuroradiologists assessed MRI images processed by MICSI-RMT and standard of care (SOC). The MICSI-RMT processed images were preferred for their clarity and reduced artifacts, achieving higher expert image quality scores compared to standard diagnostic images. Raters found that DTI images processed with MICSI-RMT had improved visualization of small structures in brain white matter and improved contrast to distinguish adjacent tissue types, and for fMRI, more anatomically appropriate activation maps.

  • Significant SNR Improvements: The software demonstrated notable enhancements in the signal-to-noise ratio (SNR), with MICSI-RMT showing improvements of up to 4.35x for diffusion MRI (dMRI) and 1.9x for functional MRI (fMRI).

  • Precise Parametric Mapping: dMRI enhancement achieved notable improvement parameter precision. Specifically, the precision of ADC maps was improved by over 56.3%.

A New Era in MRI Diagnostics

MICSI-RMT is a significant breakthrough as the first market solution designed to enhance the signal-to-noise ratio (SNR) for diffusion and functional MRI. Diffusion MRI involves the exponential signal suppression for contrast, often resulting in images with high noise levels. Similarly, the BOLD effect of functional MRI is only a few percent of the signal, which can easily be obscured by image noise. Despite the utility of these modalities in the clinical workflow, MICSI-RMT is the first solution to directly address the noise problem.

Our enhancements are particularly transformative for neuroimaging applications where precise imaging is crucial. In stroke management, especially for lesions of the posterior fossa, and in neurosurgical planning, the improved clarity and accuracy of MRI images directly impact medical decisions. Our clinical study focused on critical improvements in these areas, enabling clinicians to make more informed decisions based on clearer, more precise imaging data.

This advancement not only boosts diagnostic accuracy but also sets a new standard in neurology care, positioning MICSI-RMT as an essential tool for medical imaging professionals.

Try MICSI-RMT for yourself and see how it can be integrated into your diagnostic workflow. For more information, to schedule a demonstration, or to discuss integration options, please visit www.micsi.com or email info@micsi.com.