Nashua, N.H.-based iCAD recently announced that its PowerLook Tomo Detection received FDA premarket approval. PowerLook Tomo Detection is a concurrent-read, computer-aided detection solution for digital breast 3D tomosynthesis and is the latest innovation available on the PowerLook Breast Health Solutions platform.

“As the use of 3D mammography continues to grow in the United States and abroad, iCAD remains committed to delivering innovative solutions that help radiologists be more efficient and confident when reading tomosynthesis exams,” says Ken Ferry, CEO of iCAD. “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 United States with the potential to greatly improve clinical workflow and patient care in the years ahead.”

2D digital mammography typically produces four images per exam, while digital breast 3D tomosynthesis can produce hundreds of images, significantly increasing exam interpretation time for radiologists. PowerLook Tomo Detection improves radiologists’ efficiency by automatically analyzing each tomosynthesis plane and identifying suspicious areas. The suspicious areas are naturally blended onto a 2D synthetic image to provide radiologists with a single enhanced image that is used to more efficiently navigate the large tomosynthesis data set.

“iCAD has taken a refreshing new approach to computer aided detection,” says Justin Boatsman, MD, medical director and diagnostic radiologist at Intrinsic Imaging, LLC, who took part in the U.S. clinical study. “This innovative workflow solution detects suspicious areas on the tomosynthesis planes and that information is used to deliver an enhanced image that focuses the radiologist on the specific areas that need further investigation. This not only helps reduce the reading time and improve the reading experience for radiologists, but it can also provide radiologists with an added level of confidence.”

In a United States, clinical study conducted from October 2015 to January 2016, radiologists were able to significantly reduce reading time when reading 3D tomosynthesis exams with PowerLook Tomo Detection. The study included 20 radiologists reading 240 tomosynthesis cases both with and without the PowerLook Tomo Detection technology. Reading time was reduced by up to 37% with an average reduction of 29% when using PowerLook Tomo Detection, with no statistically significant impact on sensitivity, specificity, or recall rate. Another European clinical study was completed with six radiologists reading 80 cases and showed similar results and was the basis for CE mark of PowerLook Tomo Detection in April 2016.

“This innovative software in PowerLook Tomo Detection is built on the latest deep learning technology to significantly improve detection rates,” says Jeff Hoffmeister, MD, vice president and medical director at iCAD. “The use of deep learning has enabled us to achieve a high detection rate of 92.3%.” Deep learning is a branch of machine learning that uses sophisticated algorithms that are trained to recognize the visual characteristics of a cancer by analyzing actual patient images. The current version of the algorithm was trained using thousands of images.

PowerLook Tomo Detection, currently available on GE Healthcare digital breast tomosynthesis systems, also received CE mark and Health Canada approval in 2016, and is currently being used by multiple high volume breast imaging centers in Europe.

For more information, visit iCAD.