"The European launch of our third generation of ProFound AI for DBT demonstrates iCAD's unwavering dedication to improving breast cancer detection," said Michele Debain, Vice President, Europe, Middle East, Africa and APAC at iCAD. "Since obtaining CE Mark certification with our first generation of this technology in July 2019, ProFound AI has been installed in a growing number of medical imaging centers across Europe. ProFound AI offers benefits not only to physicians, but also to women. It helps improve workflow for radiologists and enhances their ability to accurately detect suspicious lesions and ultimately find cancers at earlier stages, which can lead to better patient management, with less burdensome treatments and increased chances of survival. This CE Mark certification will help us to bring the latest generation of our advanced technology to more physicians and women across Europe."

ProFound AI Version 3.0 was developed using over five million images from 30,000 cases, including almost 8,000 biopsy-proven cancers, and validated on approximately one million images from 3,500 cases that included 1,200 biopsy-proven cancers. The technology was also recently cleared by the U.S. Food and Drug Administration (FDA) in March 2021.


"Breast cancer is the most common cancer among women; however, the chances of survival are constantly increasing, especially thanks to technological advances in medical imaging that are improving screening performances. ProFound AI is fully in line with this desire to constantly improve radiologists' abilities to detect breast cancer as early as possible. This is why I chose to install the new generation of the ProFound AI solution in my medical imaging center dedicated to breast imaging, in order to offer my patients the best possible care," said Elena Cauzza, MD, a radiologist at Radiomedica and xDonna, a mammography and breast diagnosis center in Bellinzona, Switzerland.

In a reader study published in Radiology: Artificial Intelligence, ProFound AI for DBT Version 2.0 was clinically proven to reduce radiologists' reading time by 52.7 percent, improve radiologists' sensitivity by 8 percent, and reduce false positives and unnecessary patient recall rates by 7.2 percent.[3]

iCAD's Breast Health Solutions suite also includes ProFound AI for 2D Mammography, ProFound AI Risk, the world's first and only clinical decision support tool that provides an accurate two-year, breast cancer risk estimation that is truly personalized for each woman based only on a screening mammogram,[4] and software to evaluate breast density.

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