5 Takeaways Medical Devices

5 takeaways from the FDA’s list of AI-enabled medical devices

In 2022 alone, the FDA authorized 91 AI- or machine-learning-enabled medical devices. Devices can include anything from a basic algorithm to more complex machine learning tools. Advances in sensor technology, imaging and data analytics have helped drive the trend. The FDA is looking for faster approval of algorithm updates. The FDA has approved more AI-enabled medical devices for radiology than any other specialty. MedTech Dive studied FDA data on AI- and machine-learning-enabled devices. Here are five lessons from their rise:

  • In the last five years, there has been a dramatic increase in the number of AI-enabled medical equipment
  • In comparison to other fields of medicine, radiology has a greater number of AI-based tools. Most authorized devices have 510(k) clearance, but many aren’t required to be reviewed by the FDA
  • FDA-authorized devices are just a fraction of the AI- and machine-learning-enabled tools that exist in healthcare
  • GE Healthcare has received FDA clearance for 42 medical devices, most of which are in radiology. Siemens Healthineers had 29 cleared devices, including a feature to help visualize coronary lesions from CT scans.
  • AI- and machine-learning-enabled devices will become increasingly complex as companies move toward algorithms that “learn” as opposed to algorithms that are “locked and deployed”

The FDA is working on a pre-certification program that would allow trusted manufacturers to update their software products.

Source: Medtechdive

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