iCad (NSDQ:ICAD) today announced that the third version of its ProFound AI for digital breast tomosynthesis (DBT) has won CE mark approval.
Compared with previous software versions, the latest generation of ProFound AI offers up to a 10% improvement in specificity performance while maintaining a high sensitivity level and approximately 40% faster processing on the new PowerLook platform, according to the Nashua, N.H.-based company.
“This CE Mark certification is another momentous achievement that positions iCad in the vanguard of cancer detection and illustrates the Company’s commitment to offering leading-edge solutions that continue to be unmatched by other technologies,” said iCad CEO Michael Klein in a news release. “This regulatory milestone will provide the opportunity for our recently installed customers to upgrade to the latest version of the technology, while also expanding the potential to bring this solution to more markets — and thus more women — worldwide. This is not only consistent with our goal of establishing recurring revenue streams and predictable high margin revenues, it also stands to have a truly positive impact on patient care.”
The third generation of ProFound AI for DBT offers clinicians the ability to interpret the vast amount of data in DBT cases with greater precision and efficiency, according to the company. It is designed to rapidly analyze each tomosynthesis image and detect malignant soft-tissue densities and calcifications. Certainty of finding and case scores are assigned to each detection and each case, respectively. These are relative scores computed by the ProFound AI algorithm that represent the algorithm’s confidence that a detection or case is malignant, and may help radiologists in clinical decision-making, the company added.
ProFound AI version 3.0 was developed using over 5 million images from 30,000 cases, including almost 8,000 biopsy-proven cancers, and validated approximately1 million images from 3,500 cases that included 1,200 biopsy-proven cancers. The FDA cleared the technology in March 2021.