FDA approves AI tool for spotting wrist fractures
The FDA has been approving its fair share of AI-powered medical technology, but its latest might be particularly helpful if you ever have a nasty fall. The agency has greenlit Imagen’s OsteoDetect, an AI-based diagnostic tool that can quickly detect distal radius wrist fractures. Its machine learning algorithm studies 2D X-rays for the telltale signs of fractures and marks them for closer study. It’s not a replacement for doctors or clinicians, the FDA stressed — rather, it’s to improve their detection and get the right treatment that much sooner.
The approval came relatively quickly by using the De Novo premarket review pathway, which streamlines the process for products with “low to moderate risk.”
You may have to wait a while before you see OsteoDetect in use at the family doctor’s office. However, you might see considerably more AI going forward. FDA commissioner Scott Gottlieb recently said his administration was collaborating with experts on a “new regulatory framework” that could help the government body keep pace with technologies like AI. If that goes forward, algorithmic health care could quickly become commonplace.