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CE mark

Exini Diagnostics’ Prostate Cancer Software Cleared in Europe

May 4, 2021

Exini Diagnostics has received CE mark certification for its artificial intelligence-powered aPROMISE software, which performs quantitative assessments of prostate-specific membrane and antigen positron emission tomography/computed tomography (CT) images.

The software provides automated segmentation and marking of the CT scans, quantifying and reporting suspicious lesions in prostate cancer patients.

A clinical trial in metastatic prostate cancer patients found that the software’s sensitivity was 92 percent for regional lymph nodes, 91 percent for distant lymph nodes and 87 percent for bone, the company said.

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