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HomeLatest Pharma-NewsFDA clearance for HealthLytix for breakthrough prostate imaging solution, RSI-MRI+

FDA clearance for HealthLytix for breakthrough prostate imaging solution, RSI-MRI+

Nov 26, 2019:  HealthLytix, announced that it has received 510(k) clearance from the U.S. Food and Drug Administration for its breakthrough prostate imaging software, RSI-MRI+ which utilizes a patented advanced diffusion MRI technique called Restriction Spectrum Imaging (RSI) in order to improve early detection and diagnosis of prostate cancer by clinicians.

This software  uses artificial intelligence and an innovative tissue microstructure modelin order to increase the visibility of constrained water in the body’s tissue. All types of cancer including prostate cancer restrict or trap water.

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Conventional diffusion MRI has its limitation that it does not measure restricted water directly, instead of that it relies on a simpler measure known as the apparent diffusion coefficient (ADC).ADC is an important biomarker affected by a number of impenetrable factors that can negatively impact its sensitivity and specificity to cancer, which can result in missed or inaccurate diagnoses. https://fda.einnews.com/article__detail/503400363-healthlytix-receives-fda-clearance-for-breakthrough-prostate-imaging-solution-rsi-mri?vcode=XIbw

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