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FDA approves Bot Image’s AI software for the detection and diagnosis of prostate cancer

ProstateID combines artificial intelligence with traditional MRI scanning to significantly improve radiologic interpretation accuracy


The US Food and Drug Administration (FDA) has approved Bot Image’s AI software for use in the detection and diagnosis of prostate cancer. Bot Image is a medical device company using magnetic resonance imaging (MRI). The tool, called ProstatID, is combined with MRI scanning to ’significantly improve the accuracy and speed of prostate cancer detection and diagnosis’, the Omaha-based start-up said.

The FDA’s decision was based on two clinical studies, involving 25 radiologists from around the US, which showed that the software was able ‘to significantly improve radiologic interpretation accuracy. This was measured by improved detection and fewer false positives’ compared to assessment without AI.

The software's algorithm was trained by analysing thousands of MRI image sets, radiological interpretations, guided biopsies and pathology lab results. It recognises and measures the volume of the prostate gland, and detects suspicious cancerous lesions, assigning a cancer probability to each one and suggesting a diagnostic case score known as Prostate Imaging Reporting and Data System (PI-RADS) score.

The company said that this demonstrates a 'tremendous savings of time and cost' for the patient and provider, potentially saving lives in the process via early and accurate detection.

The tool, which is currently available for use as a software-as-a-service (SaaS) device, goes far beyond existing technologies due to its ability to detect lesions and assign a cancer probability to prostate MRI cases, the company said.

Commenting on the software, Randall Jones, Bot Image’s founder, said: "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.

"Sadly, this has resulted in the unnecessary and premature deaths of countless numbers of men in the US alone. ProstatID represents an exciting step in the fight to save lives.”

Radiology departments that sign up to the service can connect securely to Bot Image’s cloud-based servers, upload their MRI scans and then receive the AI-generated report, with the entire IT process taking less than an hour to set up, according to Jones.

The company is also working on plans to develop AI software for detecting conditions such as stroke, liver disease, chronic obstructive pulmonary disease and other cancers using MRI imaging.

Article by
Emily Kimber

10th August 2022

From: Research, Regulatory



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