SmartLight has long maintained that its motorized light box technology enables radiologists to see more detail in films. The Israeli company hopes that it will soon be able to make those claims in official marketing literature after its U.S. subsidiary
SmartLight has long maintained that its motorized light box technology enables radiologists to see more detail in films. The Israeli company hopes that it will soon be able to make those claims in official marketing literature after its U.S. subsidiary filed a 510(k) application with the Food and Drug Administration for expanded performance labeling for the products.
With its current 510(k), SmartLight can market the viewers only as a means of reading x-ray films. If the FDA clears the companys application for expanded labeling, SmartLight will market the viewers as a technology that enables radiologists to see more detail than conventional light boxes, according to Bob Sohval, president of SmartLights U.S. subsidiary in Hackensack, NJ. SmartLight backed its 510(k) filing with the results of a study, completed in January, in which over 1500 radiologists compared images on SmartLight viewers with those of conventional light boxes.
New Study Finds Racial Disparities with Pre-Op Breast MRI and Positive Surgical Margin Rates
November 8th 2024In addition to a lower rate of preoperative breast MRI use, emerging research found that Black women with breast cancer who didn’t have a preoperative MRI had a higher positive surgical margin rate than White women with no preoperative MRI.