PREDILIFE is making progress in submitting DenSeeRisk to the FDA

PREDILIFE, a company specializing in disease risk prediction, received feedback from the FDA on February 27 regarding its pre-submission for DenSeeRisk. This medical device combines artificial intelligence-based mammogram image analysis with MammoRisk to estimate breast cancer risk.

This development follows the WISDOM study, which demonstrated a reduction in advanced cancers through risk-based screening. Currently, Clairity Inc. holds the only FDA-approved device for predicting breast cancer risk.

PREDILIFE is preparing to submit an application in accordance with procedure 510(k). The objective is to demonstrate equivalence with a device authorized in the United States.