Medtech Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

Podcast: US FDA’s Artificial Intelligence Guidance May Need Congress And Is At Least A Year Away, Expert Says

Executive Summary

Zach Rothstein, the top artificial intelligence and machine learning lobbyist at device industry advocacy group AdvaMed, wrote to the US FDA with recommendations on how to regulate AI/ML devices. He sat down with Medtech Insight to break down the topic's most important issues.

You may also be interested in...



COVID-19 Shows Remote Monitoring Can Work For Pre-Cert Program

In an update to stakeholders, the US FDA says regulators can successfully evaluate a firm’s performance, allowing it to eventually get medical software to market in the agency’s Pre-Cert Program.

FDA Says AI Regulations May Require More Congressional Authorities

The top official on artificial intelligence products at the US FDA says that while the agency has some authorities to implement regulatory oversight, it may need additional powers from Congress considering the direction the FDA may possibly take in regulating AI and machine learning products.

FDA Holding February Public Meeting On Using AI In Radiology

The US agency will host a two-day meeting to discuss the evolution of artificial intelligence technology used to analyze radiological images when diagnosing patients and in advising radiologists to take optimal pictures. The takeaways from the meeting will be used by the FDA to help it develop its thinking on how to regulate such technology.

Related Content

Topics

Latest News
See All
UsernamePublicRestriction

Register

MT125430

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