Author: Carrie Hetrick | Date: December 20, 2021
Artificial intelligence (AI) is a powerful and ever-emerging technology that has the potential to improve capabilities across a multitude of industries. Medical devices with artificial intelligence hold the promise of revolutionizing the health care industry, helping medical professionals more accurately and effectively diagnose and treat their patients and improve their overall care. Along with its benefits, medical device artificial intelligence also faces challenges, including the need for regulation to keep up with the pace of technology advancement.
What is Artificial Intelligence?
Artificial intelligence is technology that mimics human activity, decision-making, and learning. In the health care industry, AI-based medical devices could:
Trends in Medical Devices with Artificial Intelligence
As technology advances, medical device companies are developing AI medical devices that serve three main functions:
FDA AI Guidance
As with any technology, AI can be flawed, creating a greater danger that medical devices with artificial intelligence could misdiagnose a patient or administer incorrect treatment. And because medical devices involve risk to a person’s health and life, they are highly regulated. Creating regulations and approval processes takes time, and the U.S. Food and Drug Administration (FDA), the governing body for medical device approval, has been unable to match the pace of technology advancement.
The current governing system is not fully equipped for FDA regulation of artificial intelligence or machine learning, which is an AI technique used to design and train software to learn from and act on data. The FDA currently approves medical devices based on their risks through one of three processes – the de-novo premarket review for low and moderate risk devices, the 510(k) process for a new device improving on an existing device or process, or the premarket approval pathway that provides the most stringent review for high-risk devices and/or brand-new technology that has never been done before. This leaves no current, specific path to approval by the FDA for artificial intelligence and machine learning in software as part of a medical device.
Earlier this year, the FDA released an action plan drafted based on stakeholder feedback gathered in April of 2019 that outlines the five actions the government entity intends to take relating to artificial intelligence at the FDA. According to the report, these five steps include:
Given that a regulation pathway is still in its early stages, having a complete picture of what an FDA approved AI medical device looks like may still be some time away.
At Sterling Medical Devices, we will continue to monitor the landscape of medical devices with artificial intelligence and impending FDA regulations. We are experts at navigating the FDA approval process for medical devices and have hundreds of success stories working with our clients. If we can provide you with superior design, development, or medical device testing services, please contact us today.
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