This is a Class 1 recall, the agency's most serious designation, suggesting failure to address these issues could "cause serious adverse health consequences or death."
The nation’s largest radiology practice is introducing an AI-based service that can warn women of looming cardiovascular risk whenever they receive a routine screening mammogram.
Some of today’s large language models may be more effective communicators than providers when it comes to explaining interventional radiology procedures.
The U.S. Food and Drug Administration highlighted concerns about "data drift," which can potentially lead to performance degradation, bias or reduced reliability.
At one academic center, reviewing a questionnaire related to body MRI orders resulted in many ordering providers doing an about-face regarding the necessity of their inpatient request.
An updated version of Heartflow's Plaque Analysis platform has gained FDA clearance. In addition, the company announced that Cigna will cover the platform going forward.
Several groups collaborated on the document, which is designed to help clinicians provide high-quality, consistent care when using flurpiridaz during cardiac PET imaging exams.