Ibex Medical Analytics Receives First FDA 510(k) Clearance, AFFIRMING Ibex’s position as a global leader in AI-powered cancer diagnostics
Ibex Medical Analytics, the leader in AI-powered cancer diagnostics, today announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for Ibex Prostate Detect, an in vitro diagnostic medical device that harnesses AI to generate heatmaps identifying small and rare missed prostatic cancers, acting as a safety net that assists pathologists in ensuring patients receive an accurate diagnosis.
"Prostate cancer is one of the most prevalent cancers worldwide, with an estimated one in eight men diagnosed in their lifetime. With the global incidence expected to double by 2040, accurate and timely diagnoses are more critical than ever. Advancements in AI-powered pathology can support pathologists in delivering precise and efficient diagnoses, ultimately improving patient outcomes,” shared Ibex scientific advisor Mahul B. Amin, MD, Vice President and Medical Director of Labcorp’s Hospital Systems Operating Division and Clinical Professor of Pathology and Laboratory Medicine at the University of Tennessee Health Science Center.