FDA Approves iCAD’s PowerLook Tomo Detection Device
New Hampshire–based iCAD has received FDA premarket approval for its PowerLook Tomo detection platform.
The device is a 3D mammography platform to detect abnormalities in the breast.
The 3D mammography platform can produce hundreds of images, significantly increasing exam interpretation time for radiologists. The 3D image improves detection of hidden or obscured areas on a 2D mammography. This platform also identifies suspicious areas that radiologists may not see initially.
The device received a CE Mark and Health Canada approval in 2016. — Cynthia Jessup