Sterling Medical Devices & RBC Medical Innovations are combining to create Vantage MedTech! Meet RBC
Contact Us
Close Form

Interested in learning more about how we can work together in your current or next medical device design project?

Just fill out this form and we’ll be in touch!

  • This field is for validation purposes and should be left unchanged.

Wherever you are in your product development lifecycle,
Sterling can help.

P: 201-877-5682
F: 201-301-9169

The Use of Artificial Intelligence in Medical Devices

Author: Carrie Britton | Date: December 20, 2021

Doctor on tablet considering medical device artificial intelligence

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:

  • Automate tasks, synthesize data from multiple sources, and pinpoint trends
  • Process and analyze information from wearable sensors and identify disease or the onset of medical conditions
  • Predict which patients are at an increased risk for disease, complications, or negative outcomes based on their medical records
  • Support research by evaluating large amounts of data and monitoring treatment efficacy

Trends in Medical Devices with Artificial Intelligence

As technology advances, medical device companies are developing AI medical devices that serve three main functions:

  • Chronic disease management Medical devices with artificial intelligence could monitor patients and deliver treatment or medication as needed. For example, diabetes patients could wear sensors to monitor their blood sugar levels and administer insulin to regulate them.
  • Medical imaging Companies are developing medical devices with artificial intelligence to conduct medical imaging with better image quality and clarity. These devices would also reduce a patient’s exposure to radiation.
  • Internet of Things (IoT) Internet of things for medical devices is a system of wireless, interrelated, and connected digital devices used by medical professionals to manage data, keep patients informed, reduce costs, monitor patients, and work more effectively and efficiently. Companies are using IoT in collaboration with medical devices with artificial intelligence to improve patient outcomes.


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:

  • Further developing the proposed regulatory framework, including through issuance of draft guidance on a predetermined change control plan (for software’s learning over time);
  • Supporting the development of good machine learning practices to evaluate and improve machine learning algorithms;
  • Fostering a patient-centered approach, including device transparency to users;
  • Developing methods to evaluate and improve machine learning algorithms; and
  • Advancing real-world performance monitoring pilots. 

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.

Share this!

Contact Us

  • This field is for validation purposes and should be left unchanged.


Man performs verification and validation testing

July 7, 2021

Do you know the difference between verification and validation?

Medical device verification and validation (V&V) are crucial steps in the medical device development process. But what’s the difference between the two, and why do we need them? Verification...
Read More >
View More Blogs
5 Mistakes Medical Device Startups Make

February 18, 2021

5 Mistakes Medical Device Startups Make

Startups are the lifeblood of medical device innovation. Without universities researching ways to solve pressing healthcare problems or doctors with experience in a particular field who have an idea to develop a prototype medical device that could help patients, the future technologies needed to help save lives wouldn't happen. But the long, arduous road through the FDA submission process to get market approval can take a long time and cost a lot of money without help. Sterling Medical Devices has been helping startups through the FDA approval process since 1998 without ever having a submission rejected.
Read More >
View More Videos

July 12, 2022

Scalp Cooling System

Overview Paxman has been pioneering scalp cooling technology for over a quarter of a century. Paxman’s clinically proven cold cap technology has helped over 100,000 cancer patients in more than 60...
Read More >
View More Case Studies

Need help with your medical device?

Let Sterling Medical Devices show how to bring your idea from concept to prototype to
FDA/CE approval with a free custom project analysis.
Request Free Analysis