The European Union approved for clinical use an AI system that recognizes normal chest X-rays.
What’s new: ChestLink is the first autonomous computer vision system to earn the European Economic Area’s CE mark for medical devices, which certifies that products meet government requirements for health and safety. The mark enables Oxipit, the Lithuanian startup that makes the system, to deploy it in the 27 E.U. countries plus Iceland, Liechtenstein, Norway, Switzerland, and Turkey.
How it works: ChestLink uses a previous Oxipit product, ChestEye, to scan for 75 abnormalities such as edema and tuberculosis. If it finds none, it generates a medical report. Otherwise it forwards the image to a radiologist for review.
- Prior to deployment in a given clinic, the company runs X-rays produced in that setting through the system to find the percentage of abnormality-free images it can recognize with high certainty. After deployment, Oxipit evaluates the system’s efficacy before letting it run autonomously.
- Oxipit tested ChestLink for a year at several clinics using 500,000 medical images.
- The company aims to deploy it autonomously next year, after which it hopes to gain approval by the United States Food and Drug Administration.
Why it matters: Reading X-ray images is highly subjective. Moreover, a radiologist’s judgment can vary as fatigue sets in over the course of a working day. By identifying and reporting on normal images, this system could help radiologists focus on the cases that need the most attention.
We’re thinking: Even the best AI systems for diagnosing chest X-rays fall short of a board-certified radiologist’s accuracy. Training AI to recognize problem-free images, which are less ambiguous, is a clever approach.