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 ex