Health technology manufacturer Koning announces that it has initiated its U.S. FDA screening trial for its no-compression, isotropic 3D breast imaging device. The company received FDA PMA approval for commercial, diagnostic use in 2017. Since then, the Koning Breast CT (KBCT) has been installed in clinics and universities in the U.S. and abroad.
“This FDA screening trial is a major milestone for radiologists and patients,” says Koning President David Georges. “An FDA cleared screening indication will allow clinics to perform breast exams with more clarity and it will permit millions of patients around the world to go into their breast imaging exams with confidence that their results will be accurate.”
What’s more, Georges says, “We are proud to be the only no-compression, true 3D breast imaging device manufacturer that already has FDA diagnostic approval; this screening trial gives us even more momentum in our push to improve breast health for all women.”
The trial, which takes place at the Port Orange Imaging Center location of the Radiology Imaging Associates group in Daytona Beach, Fla., began on Monday, November 1; FDA submission is slated for the first quarter of 2022. The kickoff of the trial starts as Breast Cancer Awareness Month comes to an end and brings more awareness to the need for better breast imaging options for women everywhere, Koning officials say.
