Final MQSA provisions go into effect
After seven years of phased-in implementation, the final provision of the Mammography Quality Standards Act (MQSA) went into effect April 28. The last rule to become law addresses patients’ rights to obtain documentation of test results,
After seven years of phased-in implementation, the final provision of the Mammography Quality Standards Act (MQSA) went into effect April 28. The last rule to become law addresses patients rights to obtain documentation of test results, ensuring that women who have mammograms will be directly notified in writing. The provision was added to the final regulations that implement MQSA, and reflects updates on the law made by the Mammography Quality Standards Reauthorization Act of 1998. The FDA estimates that most of the 10,000 U.S. mammography facilities have already met MQSA standards and are certified to perform mammography exams.
Large Study Affirms Safety of Ultrasound Enhancing Agents for Echocardiography
May 16th 2025Those receiving ultrasound enhancing agents (UEAs) for transthoracic or stress echocardiography had lower odds of all-cause death in comparison to patients who did not have UEAs, according to a nationwide study involving 11.4 million patients.
BrightHeart Garners Third FDA Clearance for AI-Powered Assessments of Fetal Heart Ultrasound
May 14th 2025The latest FDA 510(k) clearance is for B-Right Views, an AI-enabled device, which provides automated detection of required views necessary for second- and third-trimester fetal heart ultrasound exams.
