FDA Clears Two Siemens Healthineers AI-Based MRI Interpretation Tools

Siemens Healthineers announced Wednesday it has secured 510(k) clearance from the U.S. Food and Drug Administration for two new artificial intelligence-based software assistants to assist with MRI scans.

These tools will be added to the company’s AI-Rad Companion suite of products, officials said. The AI-Rad Companion Brain MR for Morphometry Analysis segments brain MRI images, measuring brain volume and calculating volume deviations. Additionally, the AI-Rad Companion Prostate MR for Biopsy Support automatically segments prostate MRI images, allowing radiologists to easily mark lesions and facilitate targeted prostate biopsies.

“These new AI-Rad Companion applications for MR exams in the brain and prostate regions will help physicians manage their workloads and achieve a patient-focused decision-making process to increase efficiency and improve the quality of care,” said Peter Shen, vice president of innovation and digital business at Siemens Healthineers North America.

According to company details, the Brain MR product supports brain volumetry with measuring and determining volume changes in gray matter, white matter, and cerebrospinal fluid in the approximately 30 segments of the brain. Previously, radiologists have performed segmentation and comparisons manually or semi-automanually, but this AI-Rad product sends results to a report where deviations from normal levels are automatically flagged. Being able to recognize these changes is clinically important, they said, because reduced volume can point to Parkinson’s disease, Alzheimer’s disease, or other types of dementia.

The Prostate MR tool also automatically segments the prostate, marking the organ’s outer contour in only a few seconds versus the several minutes it takes to do so manually, according to company information. The radiologist marks the suspicious area and sends an annotated MRI report to the urologist that can be fused with ultrasound images during biopsy. Together, these exams can help the urologist identify significant prostate carcinomas.

Both software assistants are DICOM-compliant and can be used with Siemens Healthineers MRI scanners, as well as outside manufacturers. They are available on Siemens’ teamplay cloud-based digital health platform and can be easily be integrated into an existing clinical workflow.