FDA Clears Emerging AI Software Application for Prostate MRI
Prostate AI reportedly enhances lesion detection, reduces segmentation variability between radiologists and improves workflow efficiencies in biopsy-recommended cases.
The Food and Drug Administration (FDA) has granted 510(k) clearance for Prostate AI, a software application for prostate MRI that may bolster lesion detection as well as workflow efficiency.
As part of DeepHealth’s Prostate Suite software platform,
• automated lesion detection and risk classification;
• a combination of gland segmentation and prostate-specific antigen (PSA) density calculation; and
• PI-RADS compliant reporting compatible with 11 fusion biopsy systems.
DeepHealth noted that real-world research has shown that incorporation of Prostate AI, which has also received a CE mark, has led to a 27 percent improvement in lesion detection and a 65 percent reduction in inter-radiologist segmentation variability. Prostate AI also led to a 37 percent reduction in workflow time in biopsy-recommended cases, according to the company.
“One of AI’s most significant contributions in prostate cancer detection is expanding access to prostate screening. Solutions like DeepHealth Prostate Suite support radiologists throughout the reporting workflow, minimizing delays and helping ensure more men receive timely, accurate care,” said Francesco Giganti, MD, an associate professor of radiology at University College London.
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