AI & the FDA

Taking a detailed look at the recent upward trend of FDA approvals for medical devices that use Artificial Intelligence (AI) as well as looking at culture shifts with respect to AI and healthcare in other parts of the world such as the EU, China, UK and Canada

2018 was a defining year for medical devices that utilize artificial intelligent algorithms. Even though medical devices have been using ‘software algorithms’ to help assist clinicians, 2018 saw the first FDA approved medical device that uses artificial intelligence and doesn't require a clinician to interpret the input.

The last 6 months have seen an increase in FDA approvals and we can expect to see even more approvals. Verbiage used in some of these FDA approvals include ‘analyzing radio-logical images using machine learning algorithms to detect and diagnose fractures’,

‘Using artificial intelligence algorithms, the device is able to determine whether a patient has referable retinopathy’