Becker's Healthcare April 15, 2019
The FDA grants approval for drugs and medical devices, but as artificial intelligence continues to grow in healthcare, the agency also is tasked with ensuring computer algorithms are both safe and effective, NPR reports.
In 2018, the FDA approved IDx-DR, an AI-powered software that can identify whether a patient’s vision is beginning to erode due to diabetic retinopathy. The agency said it was the first time it approved a device that can make a screening decision without a clinician’s interpretation, according to the report.
Seven things to know:
1. Medical software often undergoes a less “rigorous pathway,” for FDA approval than medical devices, NPR reports.
2. IDx-DR CEO and Founder Michael Abramoff, MD, PhD, told NPR that when he started...