“It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA,” according to the warning letter. These issues, the agency added, “may be symptomatic of serious problems in your firm’s manufacturing and quality management systems.”

Cardiology is linked to the second largest group of FDA-cleared clinical AI algorithms, and the number is still growing. 

The video-based deep neural network showed potential for limiting invasive exams and improving patient care. 

Researchers found that echocardiographers in the cath lab are exposed to high doses of radiation on the right half of their body, especially the waist and lower body. 

The American Society of Echocardiography (ASE) released a new guideline document that outlines uniform training standards for interventional sonographers guiding structural heart procedures.

Overall, cardiologists made corrections to 16.8% of AI-generated assessments and 27.2% of sonographer assessments.

Cardiology has the second largest number of FDA-cleared AI algorithms, and many of them are for cardiac ultrasound. Echocardiography expert Patricia A. Pellikka, MD, discusses this trend and how AI is helping improve echo.

The recommendations were developed by a writing group comprised of experts from different specialties, offering an array of perspectives and approaches.