AI-ML enabled medical devices is a fast-moving field still subject to many speculations. Analyzing the AI/ML regulatory approvals landscape, based on regulatory precedents, will help inform regulatory strategies and showcase important aspects that supported the regulatory decisions.
What is the most common approval pathway? the average approval time ? In which area are we seeing the most of approvals? What medical devices classification was the most represented?
For all AI/ML-based medical devices listed on the FDA database, the following characteristics were collected: device name, manufacturer, review panel, regulatory pathway, time for approval, Regulatory MD classification, regulation name. Time range goes from 11/08/1995 to 07/29/2022

A review of Artificial Intelligence and Machine Learning (AI/ML) - Enabled Medical Devices approvals in the US

For it's 35th anniversary, DIA Europe is back in Basel, where all thought leaders meet in person to discuss, inspire, and network.

Join us in Basel: March 22-24, 2023

DIA Europe 2023 is designed to drive insights into action by connecting key policy discussions to real-world knowledge that you need for your everyday job. Your participation will accelerate your growth and your organization's performance in the drug development ecosystem.

Gathering innovative thought leaders from the entire life science landscape, DIA always has the aspiration to be ahead of current developments, reflected by 4 new content tracks in 2023:

- Artificial Intelligence and Data Science
- EU Health Policy and Regulatory Strategy
- Medical Devices and Combination Products
- Professional Development

DIA Europe 2023

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