FDA approves iCAD’s new AI solution for DBT

iCAD has received FDA clearance for its ProFound AI solution, which uses artificial intelligence (AI) to help radiologists detect cancers in digital breast tomosynthesis (DBT) images.

At RSNA 2018 in Chicago, the company presented results of a large reader study that found ProFound AI can increase cancer detection rates, reduce false positive rates and speed up interpretation times.

“This enables us to offer clinicians globally an unrivaled cancer detection and workflow solution built on the latest advances in deep-learning,” Stacey Stevens, executive vice president and chief strategy and commercial officer at iCAD, said in a prepared statement. “Clinical reader study results and comprehensive stand-alone testing have shown unprecedented improvements in both clinical performance and reading efficiency. We are proud to introduce revolutionary technology that will fundamentally transform breast cancer detection and patient care.”

“This technology shows tremendous promise in assisting radiologists in detecting cancers, reducing recalls and increasing efficiency when reading tomosynthesis studies,” Emily Conant, MD, department of radiology at the Hospital of the University of Pennsylvania in Philadelphia, said in the same statement. “Clinical data shows that when tomosynthesis readers use the ProFound AI algorithm, case-level sensitivity is improved by 8 percent on average and reading times are significantly decreased. Radiologists with various levels of expertise may benefit from this AI-driven technology when reading large tomosynthesis data sets.”