The state of artificial intelligence-based FDA-approved medical devices and algorithms: an online database | npj Digital Medicine

At the beginning of the artificial intelligence (AI)/machine learning (ML) era, the expectations are high, and experts foresee that AI/ML shows potential for diagnosing, managing, and treating a wide variety of medical conditions. However, the obstacles to the implementation of AI/ML in daily clinical practice are numerous, especially regarding the regulation of these technologies. Therefore, we provide an insight into the currently available AI/ML-based medical devices and algorithms that have been approved by the US Food & Drugs Administration (FDA).

We aimed to raise awareness of the importance of regulatory bodies, clearly stating whether a medical device is AI/ML-based or not. Cross-checking and validating all approvals, we identified 64 AI/ML-based, FDA-approved medical devices and algorithms. Out of those, only 29 (45%) mentioned any AI/ML-related expressions in the official FDA announcement. 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. We have launched the first comprehensive and open-access database of strictly AI/ML-based medical technologies that have been approved by the FDA. The database will be constantly updated.

Ask your doctor how he uses AI for his medical practice

The state of artificial intelligence-based FDA-approved medical devices and algorithms: an online database | npj Digital Medicine