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iCAD Announces FDA Clearance of ProFound AI for Digital Breast Tomosynthesis
Dec. 07, 2018 08:23AM PST
Medical Device InvestingiCAD (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 …
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.”