Becker's Healthcare December 18, 2024
Just one in five devices approved by the FDA for children actually included pediatric data in their algorithms, a recent Boston Children’s study found.
1. The study, published Dec. 16 in JAMA Pediatrics, analyzed 876 artificial intelligence and machine learning-enabled medical devices. Of those devices, 549 were authorized after 2021 and 853 were authorized through the FDA 510(k) clearance pathway. The most common medical specialties were devices were radiology (76.1%), cardiovascular use (10.4%) and neurology (3.5%).
2. Researchers found that only 17%, or 149 devices, were explicitly labeled for use in children, and of those, 19% explicitly reported development using...
Today's Sponsors
Today's Sponsor