Bot Image’s ProstatID AI Software Gains FDA Nod

MRI medical device firm Bot Image has obtained U.S. Food and Drug Administration (FDA) clearance for its artificial intelligence (AI)-driven CAD software to improve speed and accuracy of prostate cancer detection (CADe) and diagnosis (CADx).
 
The ProstatID tool combines AI with traditional MRI scanning.
 
“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,” company founder and CEO Dr. Randall W. Jones told the press. “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.”
 
The software’s algorithm was trained by analyzing thousands of MRI image sets, radiological interpretations, guided biopsies, and pathology lab results. It recognizes and measures the prostate’s volume and spots cancerous lesions, assigning a cancer probability to each one and suggesting a diagnostic case score called PI-RADS (Prostate Imaging Reporting and Data System).
 
The computer-aided design tool is available as a software-as-a-service (SaaS) device, needing only a secure VPN tunnel connections between the radiology department server or MRI system and cloud-based ProstateID server.
 
“With FDA clearance, the path for implementation is open,” said Jones, “and hospitals and radiological clinics can connect in as little as one hour of IT effort, and begin bringing this exciting technology to their patients.”