Predilife Achieves Key Milestone: FDA Clears Path for DenSeeRisk
Predilife announces receiving feedback from the Food and Drug Administration (FDA) on its pre-submission for DenSeeRisk, a medical device that combines mammography image analysis with artificial intelligence and breast cancer risk prediction. This feedback enables the company to proceed with the full submission of the application under the 510(k) procedure.
Innovative Combination of Technology and Risk Assessment
DenSeeRisk integrates two distinct modules: an artificial intelligence image analysis module for automated assessment of breast density from mammograms, and a MammoRisk risk estimation module that combines imaging information with clinical data and a polygenic score to calculate an individual's five-year breast cancer risk estimate. The device is part of Predilife's strategy, which focuses on innovative risk prediction solutions for personalized medicine.
Comprehensive Submission Process Scheduled for March 2026
The complete submission of DenSeeRisk to the FDA is scheduled for March 2026 under the 510(k) procedure, which is based on demonstrating substantial equivalence to a device already authorized on the American market. The standard review period by the FDA for this procedure is up to three months, in addition to further communications with the company.
