Dive brief:

• Clarity raised $43 million to commercialize a platform that predicts a woman’s breast cancer risk over five years, the company said Thursday.
• The Clarity Breast platform uses artificial intelligence to analyze 2D mammography images. Clarity granted de novo permission for the item in June
• With the new Series B funding, Clairity plans to accelerate US commercialization and expand partnerships with leading imaging centers and health systems.

Diving Insight:

Clarity trained its AI model on mammogram images matched with five years of outcome data. The process was designed so that the model could identify patterns in breast tissue that correlate with future cancer development.

FDA de novo approval supported the use of the model to predict future risk of breast cancer. With regulatory hurdles to market cleared, ACE Global Equity and Santé Ventures have launched a funding round to support commercialization. Clairity said it initially targeted „marquee health systems” and is now ready to expand its deployment.

A commercial partnership is underway, Clairity CEO Jeff Luber said in a statement. Funding will support reimbursement initiatives and partnerships to make Clarity Breast available in community imaging centers across the country.

The funding will also support Clarity’s R&D plans. The company’s pipeline includes Clarity Breast 3D and Clarity Heart, designed to predict cardiovascular risk from a routine imaging test. The move to cardiovascular disease is part of an effort to use the deep learning framework that underpins Clairity Breast to create AI-powered predictive suggestions in other treatment areas.