The US Food and Drug Administration has granted FDA market authorization to Paige Prostate, a clinical-grade AI solution for prostate cancer detection. This ground-breaking approval means that Paige Prostate is the first and only AI-based pathology product to receive market authorization for in vitro diagnostic (IVD) use.
This FDA approval marks the beginning of a new era of clinical care where pathologists will be able to leverage computational pathology products like Paige Prostate to enhance their ability to make a diagnoses and lead to improved patient outcomes.
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