The US Food and Drug Administration (FDA) has granted premarket approval (PMA) to image analysis provider iCAD's PowerLook Tomo Detection.
PowerLook Tomo Detection is a concurrent-read computer aided detection technique for digital breast 3D tomosynthesis.
Designed for cancer detection and workflow, the new solution leverages deep learning technology to improve efficiency and minimise reading time.
While 2D digital mammography generates four images per exam, a digital breast 3D tomosynthesis can produce hundreds of images, resulting in increased exam interpretation time.
PowerLook Tomo Detection automatically analyses each tomosynthesis plane and detects suspicious areas, which are naturally blended onto a 2D synthetic image to offer single enhanced image.
iCAD chief executive officer Ken Ferry said: "As the use of 3D mammography continues to grow in the US and abroad, iCAD remains committed to delivering innovative solutions that help radiologists be more efficient and confident when reading tomosynthesis exams.
"FDA approval of PowerLook Tomo Detection is a significant milestone for the company and we are positioned to rapidly advance our commercial plan for this innovative technology in the US with the potential to greatly improve clinical workflow and patient care in the years ahead."
PowerLook Tomo Detection was evaluated in a clinical study conducted from October 2015 to January 2016, which involved 20 radiologists reading 240 tomosynthesis cases.
The results showed that the solution has significantly decreased reading time when reading 3D tomosynthesis exams compared to reading without the solution.
PowerLook Tomo Detection has obtained CE mark in April last year based on another European study which included six radiologists reading 80 cases with similar results.