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Previously submitted to: Journal of Medical Internet Research (no longer under consideration since Mar 30, 2020)

Date Submitted: Mar 25, 2020
Open Peer Review Period: Mar 25, 2020 - Mar 30, 2020
(closed for review but you can still tweet)

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The state of artificial intelligence-based FDA-approved medical devices and algorithms: An online database

  • Bertalan Mesko; 
  • Stan Benjamens; 
  • Pranavsingh Dhunnoo; 

ABSTRACT

Background:

At the beginning of the artificial intelligence (A.I.) era, the expectations are high, and experts foresee that A.I. shows potential for diagnosing, managing and treating a wide variety of medical conditions. However, the obstacles for implementation of A.I. in daily clinical practice are numerous, especially regarding the regulation of these technologies.

Objective:

Therefore, we provide an insight into the currently available A.I.-based medical devices and algorithms that have been approved by the U.S. Food & Drugs Administration (FDA). We aimed to raise awareness about the importance of regulatory bodies, clearly stating whether a medical device is A.I.-based or not.

Methods:

Cross-checking and validating all approvals, we identified 64 A.I.-based, FDA approved medical devices and algorithms. Out of those, only 29 (45%) mentioned any A.I.-related expressions in the official FDA announcement.

Results:

The majority (85.9%) was approved by the FDA with a 510(k) clearance, while 8 (12.5%) received de novo pathway clearance and one (1.6%) premarket approval (PMA) clearance. Most of these technologies, notably 30 (46.9%), 16 (25.0%) and 10 (15.6%) were developed for the fields of Radiology, Cardiology and Internal Medicine / General Practice respectively.

Conclusions:

We launched the first comprehensive and open access database of strictly A.I.-based medical technologies that have been approved by the FDA. The database will be constantly updated. 


 Citation

Please cite as:

Mesko B, Benjamens S, Dhunnoo P

The state of artificial intelligence-based FDA-approved medical devices and algorithms: An online database

JMIR Preprints. 25/03/2020:18882

DOI: 10.2196/preprints.18882

URL: https://preprints.jmir.org/preprint/18882

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