Medical technology innovators have been providing AI/ML-enabled devices to the healthcare community for three decades with over 900 technologies authorized by FDA to date.

On October 19th, the FDA published its 2023 list of authorized AI-enabled medical devices. This year 171 additional medical devices were added to the list; a 33% increase in one year.

Sep 11, 2020 · 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...

Jan 6, 2025 · Today, the U.S. Food and Drug Administration issued draft guidance that includes recommendations to support development and marketing of safe and effective AI-enabled devices throughout the...

Oct 9, 2024 · AI-enabled medical devices can be used to improve the quality of images, reduce scan times and help clinicians make a diagnosis or prepare for surgery. MedTech Dive analyzed the FDA’s list at the end of September. The data show a steep increase in the number of AI-enabled devices going through the regulator over the past 10 years.

Artificial Intelligence (AI) is a broad conceptual category of computer software that is designed to mimic, emulate, or improve human decision-making. There are two broad categories of AI: rules-based expert systems (ES), and machine-learning (ML) systems.

May 9, 2022 · Artificial Intelligence/ Machine Learning (AI/ML)-Enabled Medical Devices: Tailoring a Regulatory Framework to Encourage Responsible Innovation in AI/ML

Mar 8, 2023 · In this article, we discuss the existing FDA programs and recently issued guidance impacting AI/ML technologies intended for use in healthcare, as well as what to expect from the FDA’s fiscal year (FY) 2023 priority list. We also examine the reimbursement framework for AI/ML and some challenges ahead for the medical device industry.

Today, the U.S. Food and Drug Administration released the agency’s first Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan. This action plan...

Jan 18, 2023 · The FDA granted accelerated approvals of medical devices with AI in 2022, which is expected to continue through 2023. As more AI-based tools and devices are approved, providers can include AI in their everyday practice.