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

Regulatory Briefs: HHS Agenda; Cardiopulmonary Blood Pump Reclassification; FDA Meetings

This article was originally published in The Gray Sheet

Executive Summary

HHS issued a semiannual report detailing the regulatory agenda for FDA in 2014. FDA reclassifies cardiopulmonary bypass blood pumps. More regulatory news.

You may also be interested in...



Research Briefs: Edwards Starts New Sapien 3 Trial; Upper Airway Stimulator For Sleep Apnea

FDA has approved an investigational device exemption for Edwards Lifesciences’ trial of the Sapien 3 transcatheter aortic valve in intermediate-risk patients. The New England Journal of Medicine publishes results of the STAR trial of Inspire Medical’s upper airway stimulator for treatment of sleep apnea.

Obstructive Sleep Apnea: CPAP Under Pressure As New Market Segments Awaken

An estimated 15 million Americans have obstructive sleep apnea severe enough to warrant treatment, but this field has been chronically underserved by traditional continuous positive airway pressure systems that are inconvenient and uncomfortable to use. To address this problem, CPAP manufacturers are making design improvements to optimize comfort and compliance; at the same time, promising new technologies are emerging – including neurostimulation devices for OSA – that could help reshape the future management of this often overlooked, but serious disorder.

Science Board Investigates How FDA Has Responded To Critical 2007 Report

A subcommittee is evaluating progress the agency has made in regulatory science since the 2007 report, “FDA Science and Mission at Risk,” was issued, while identifying future needs.

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

MT032997

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