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

AI & Regulation: AdvaMed Aims To Mold Artificial Intelligence Policy For Device Industry

Executive Summary

As AI becomes more prevalent in the medical device arena, thought-leaders in industry and US FDA are looking down the road at how artificial intelligence can be regulated in a way that doesn't stymie innovation. AdvaMed is helping to lead the charge by crafting policy points to address the issue.

You may also be interested in...



'Excellence' In Health-Software Design: US FDA Taps Nine Firms To Figure Out What That Means

The likes of Apple, Samsung and FitBit join traditional medtech players Johnson & Johnson and Roche, along with digital-health startups in a new US FDA pilot program intended to define best-practice software design as a means to "pre-certify" companies and reduce pre-market requirements. FDA's Bakul Patel and the CEO of one pilot participant, Pear Therapeutics, weighs in.

Speaking Of Medtech, Ep. 10: FDA’s TAP Pilot

In this FINAL EPISODE of Speaking Of Medtech: The US FDA got something it desperately wanted in its latest user-fee package with industry: a Total Product Lifecycle Advisory Program pilot, or TAP. The agency says TAP will allow for earlier and more frequent engagement with developers – but is it needed?

Thumbs Up: FDA Authorizes Weight Loss Suturing Systems From Apollo Endosurgery

People with obesity now have new tools to help them lose weight, thanks to the US agency’s de novo authorization.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

MT121633

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