FDA Approves PowerLook Tomo Detection for Speeding Up 3D Mammography Image Reading

FDA Approves PowerLook Tomo Detection for Speeding Up 3D Mammography Image Reading

The U.S. Food and Drug Administration has granted premarket approval to iCAD‘s PowerLook Tomo Detection technology, which allows radiologists to read 3D mammography images much faster.

The technology not only speeds up the exam-reading process, but maintains 3D tomosynthesis’ ability to spot abnormal tissue with precision, iCad said.

Premarket approval essentially means a company is authorized to market a healthcare technology.

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

Two-dimensional digital mammography usually produces four images per exam, while 3D tomosynthesis produces hundreds. Three-dimensional tomosynthesis is far better at detecting abnormal areas in a woman’s breast, finding 41 percent more invasive cancers than 2D mammography and reducing false positives by up to 37 percent.

But it significantly increases the time it takes radiologists to interpret exams.

PowerLook Tomo Detection helps radiologists read exams faster. It does this by automatically analyzing each tomosynthesis plane and identifying suspicious areas in the breast. Then, it blends the suspicious regions onto a 2D image. The single image gives radiologists a quick grasp of the tomosynthesis data set.

ICad used deep learning to build the PowerLook Tomo Detection algorithm. This meant training the software to use thousands of actual patient images to recognize the visual characteristics of a cancer.

The company conducted a U.S. clinical trial on the technology between October 2015 and January 2016. It showed that PowerLook Tomo Detection could reduce 3D tomosynthesis reading time an average of 29.2 percent and up to 37 percent. The technology maintained 3D’s high sensitivity — an ability to detect up to 92 percent of visible cancers.

The study included 20 radiologists who read a total of 240 3D tomosynthesis with and without using the algorithm.

In another study, six radiologists read 80 3D tomosynthesis and obtained similar results. The study was the basis for the CE Mark that the United States granted to PowerLook Tomo Detection in April of 2016.

“ICAD has taken a refreshing new approach to computer aided detection. 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,” said Justin Boatsman, MD, medical director and diagnostic radiologist at Intrinsic Imaging, who took part in the U.S. clinical study. “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.”