NEW YORK — Israeli diagnostics firm Ibex Medical Analytics said on Thursday that it has received CE-IVD marking for its artificial intelligence-based prostate cancer detection system.
Called Galen Prostate, the system is designed to help pathologists detect and grade prostate cancer in biopsies. It uses an algorithm the company said was trained on slides from a dataset of over 60,000 prostate slides from multiple institutions and representing a variety of diagnoses and clinical findings.
In a prospective clinical study comparing Galen Prostate against consensus diagnosis between multiple pathologists, the system achieved an area under the curve of .997, with a sensitivity of 98.6 percent and specificity of 95.6 percent, Ibex said.
"We hit an important milestone with the CE-IVD mark, facilitating a wider adoption of Galen Prostate in the market," Ibex CEO Joseph Mossel said in a statement. "These clinical-grade results confirm our robust and meticulous approach to AI, that corresponds to the pathologist's own workflow."