iCAD Announces FDA Clearance of ProFound AI for Digital Breast Tomosynthesis

iCAD (NASDAQ:ICAD), a global medical technology leader providing innovative cancer detection and therapy solutions, today announced clearance by the United States Food and Drug Administration (FDA) for their latest, deep-learning, cancer detection software solution for digital breast tomosynthesis (DBT), ProFound AI™, clearing the technology for commercial sales and clinical use in the United States.

As quoted in the press release:

The powerful solution built on artificial intelligence (AI) is now available to healthcare facilities in the U.S., providing access to the most cutting-edge breast cancer detection software in the marketplace today.

“Obtaining FDA clearance for ProFound AI opens a new and substantial addressable market for iCAD. This enables us to offer clinicians globally an unrivaled cancer detection and workflow solution built on the latest advances in deep-learning,” said Stacey Stevens, Executive Vice President and Chief Strategy and Commercial Officer at iCAD. “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.”

Click here to read the full press release.