Radiology

The American College of Radiology and the Radiological Society of North America told the FDA that generative AI-enabled medical devices need strong postmarket monitoring alongside any regulatory flexibility, according to comments both societies submitted Oct. 19 on the agency’s generative…

Rochester, Minn.-based Mayo Clinic will evaluate a new GE HealthCare SPECT/CT imaging system designed to support theranostics. Mayo Clinic is one of five institutions worldwide participating in GE HealthCare’s clinical evaluation program for the StarGuide GX system, according to an…

Automated breast ultrasound was associated with fewer short-interval follow-up recommendations than handheld ultrasound among women with dense breasts, with no apparent difference in cancer detection, according to a study published in the Journal of the American College of Radiology. Here…

Indianapolis-based Indiana University Health has become the first health system in the U.S. to administer Pixclara, a newly FDA-approved brain cancer imaging drug. The drug is approved for use in adults and children with suspected recurrent glioma, according to an…

The American College of Radiology issued guidance cautioning clinicians against using the Breast Imaging Reporting and Data System to guide care for most pediatric breast masses. BI-RADS was developed for adult breast imaging, and applying its categories to children and…

New York City-based NYU Langone Health has opened a 28,000-square-foot imaging center in Manhattan. NYU Langone Radiology—Upper West Side offers imaging for breast, neurological, cardiovascular and cancer care, according to an Oct. 12 news release. The center’s technology includes integrated…

Maryland has become the first state to require mammography centers to notify patients when their scans show breast arterial calcification, which has been linked to elevated cardiovascular risk. The requirement took effect Oct. 1 and requires centers to tell patients…

Radiology dominated FDA authorizations of AI- and machine learning-enabled medical devices through 2025, according to a peer-reviewed study published in Cureus. The study examined 1,430 authorization records in the FDA’s public AI-enabled device list with authorization dates from September 1995…

GE Healthcare announced Oct. 5 a definitive agreement to acquire SOFIE Biosciences, a Positron Emission Tomography radiopharmaceutical company, for $945 million in cash.  SOFIE Biosciences manufactures PET radiopharmaceuticals including Flyrcado (flurpiridaz F18 injection), which the FDA approved in 2024 to…

Fredericksburg, Va.-based Mary Washington Healthcare has opened the Mary Washington Interventional Radiology Outpatient Clinic on the Stafford Hospital campus and hired its first interventional radiologist. The outpatient clinic provides evaluation, consultation and treatment for a range of conditions using imaging…