FDA clears AI software for spotting prostate cancer in MRI scans

A small, Nebraska-based company has received FDA clearance for artificial intelligence-driven software that helps pick out the signs of prostate cancer in MRI scans.

Bot Image’s ProstatID program was trained using thousands of digital images, radiologist interpretations and biopsy results. It automatically recognizes and measures the volume of the prostate gland and highlights suspicious lesions that could be harboring tumor cells.

“Prostate cancer screening and detection methods adoption has changed little over the past 30 years, despite the mountain of evidence pointing to the efficacy of superior technologies and the futility of the old methods,” CEO Randall Jones said in a statement. “Sadly, this has resulted in the unnecessary and premature deaths of countless numbers of men in the U.S. alone.”

In addition, the prostate itself can pose a challenge when it comes to getting a clear scan, due to its location within the body and the uniformity of its tissue, the company noted. 

To assist in making a cancer diagnosis, Bot Image’s machine learning algorithms are designed to produce a colorized map of normal and abnormal tissue. The program also assigns a probability score to each lesion—derived from T2, apparent diffusion coefficient and diffusion-weighted images.

The company plans to offer ProstatID, its first product, as a software-as-a-service. Radiologists will connect with Bot Image’s cloud-based servers, upload their MRI scans and receive an AI-generated report in return, with the entire IT process taking less than an hour to set up, according to Jones.

Bot Image—a company originally incubated at the MRI coil provider ScanMed—also plans to develop AI software for detecting conditions such as stroke, liver disease, chronic obstructive pulmonary disease and other cancers using MRI imaging.