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

“First-Of-A-Kind” Aerocrine NIOX Nitric Oxide Asthma Test Gets FDA Nod

This article was originally published in The Gray Sheet

Executive Summary

Aerocrine's NIOX asthma monitoring test will allow physicians to closely evaluate the efficacy of asthma therapy in a non-invasive manner, following FDA 510(k) clearance, announced May 1

You may also be interested in...



New Products In Brief

Spiral lead CE mark: Boston Scientific will market its Acuity Spiral left ventricular lead by mid-March outside the United States for use with cardiac resynchronization therapy devices to treat heart failure. The product boasts a 4-French lead tip profile, the smallest tip in the industry, the firm says. Boston Scientific anticipates U.S. approval of the lead by July

New Products In Brief

Spiral lead CE mark: Boston Scientific will market its Acuity Spiral left ventricular lead by mid-March outside the United States for use with cardiac resynchronization therapy devices to treat heart failure. The product boasts a 4-French lead tip profile, the smallest tip in the industry, the firm says. Boston Scientific anticipates U.S. approval of the lead by July

Nitric oxide tests get special controls

Devices are officially downclassified from Class III to Class II in July 7 final rule. A breath nitric oxide test system Class II special controls guidance accompanies the rule. The downclassification was prompted by a petition from Aerocrine AB. The device, which aids in monitoring asthma therapy, received 510(k) clearance earlier this year, following an April 30 classification order (1"The Gray Sheet" May 5, 2003, p. 26)...

Latest Headlines
See All
UsernamePublicRestriction

Register

MT018323

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