Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

FDA Issues 5-Point Action Plan For Artificial Intelligence/Machine Learning-Based SaMD

Executive Summary

A new guidance document and a promise to hold a public workshop are just two commitments made by the US agency in a 12 January action plan aimed at AI/ML-based software as a medical device.

You may also be interested in...



Head Of New Digital Health Center Looking For A Few Good FDA Staff

Bakul Patel, director of the US agency’s new Digital Health Center of Excellence, tells Medtech Insight he’s looking to hire staff that want to shape the digital health regulatory landscape.

Newly Cleared Cardiac Ultrasound Software Could Broaden Imaging User Base

The US FDA has cleared Caption Guidance software, an AI package that guides users through cardiac ultrasounds to help them capture the best images. In clinical trials, the system allowed untrained nurses to gather diagnostic-quality pictures and videos.

Rise Of The Machines: FDA Artificial Intelligence Guidance Is Coming

US FDA says as artificial intelligence and machine learning offer new opportunities to improve patient care, the agency hopes to encourage innovation by developing a draft guidance on the issue for sponsors. It also released a discussion paper outlining key issues it wants feedback on from industry and other key stakeholders.

Topics

UsernamePublicRestriction

Register

PS051363

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel