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


Device Innovation: Report Paints Dire Picture; Prez, FDA Take "Positive" Steps

This article was originally published in The Gray Sheet

Executive Summary

Last week started off with a particularly negative appraisal for the prospects of continued U.S. leadership in medical device innovation under current policies, but it was followed by two developments that almost appeared as corrective responses by the federal government.

You may also be interested in...

Regulatory News In Brief

Regulatory updates from FDA and the White House.

FDA Will Not Broadly Release Report Criticizing EU Oversight

The agency decided not to widely disseminate a report examining 12 high-risk devices that were approved in Europe, but were later found to be dangerous or ineffective.

President Cites “Faulty Medical Devices” In State Of The Union

State of The Union address references “faulty medical devices” with financial fraud and toxic dumping as things in need of smart regulation. The policy significance, if any, is unknown, but the subtext appears to be a subtle shift from mentions of the industry by the president in 2011.

Related Content




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