FDA Approvals For Smart Algorithms In Medicine In One Giant Infographic

We strongly believe that only digital health can bring healthcare into the 21st century and make patients the point-of-care. Mental health algorithms mimicking empathy? A.I. outsmarting human doctors? Simple big data analytical software presented with clever marketing tactics? It’s difficult to assess the actual state of play when it comes to artificial intelligence in healthcare. Moreover, there’s no database that contains all the smart algorithms worth applying to medical processes. That’s the reason why we decided to collect every artificial intelligence-based algorithm that already received FDA approval – meaning that they are proven, reliable, and accurate solutions enabled by an official regulator for medical use. Let’s see the infographic in details!

The factors of algorithmic healing When we started to assess the universe of smart algorithms in healthcare, we took into account temporal and spatial factors, accuracy and credibility, as well as medical specialties where A.I. algorithms have a chance to make the care process better.

Concerning the timeline, we noticed an uptake in the appearance of new solutions in the last years, and you can see that also in the infographic. In 2014, only AliveCor’s algorithm for the detection of atrial fibrillation was approved. Two years later, the FDA found further four solutions ready for clinical use, while in 2017, six new algorithms were approved by the US regulator. This exponential growth just accelerated last year, when the FDA endorsed 23 algorithms in medicine. As the first approvals in 2019 also show, we do not expect the trend to slow down. On the contrary, we will most likely see dozens of new medical A.I. solutions on the market.

Looking at the spatial factors, while the most important hubs for A.I. development are the Silicon Valley, the Boston-New York area, Montréal, London, Bangalore, and Beijing, and the same can be applied in medicine and healthcare, the most decisive factor for compiling FDA approved algorithms was that it is the only yardstick for credible and accurate medical software. Although in Europe, the European Medicine Agency has guidelines and statements about artificial intelligence, the FDA is the only regulator with efficient instruments in its toolkit to access the credibility and accuracy of algorithms for medical purposes in detail. It also means that we had to stay on the U.S. market and consider the developments within the FDA’s jurisdiction.