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

CryoCath clarification

This article was originally published in The Gray Sheet

Executive Summary

FDA-approved labeling for CryoCath's Freezor ablation catheter, PMA-approved April 22, includes directions for performing cryomapping prior to cryoablation of atrioventricular node re-entry tachycardia. However, the Freezor's instructions for use do not list cryomapping as a specific indication, as was reported in "The Gray Sheet" (April 28, p. 5)...

You may also be interested in...



Freezor modification

CryoCath's FreezorXtra, the larger version of the Freezor cryoablation catheter, is now available to a limited number of U.S. electrophysiologists after earning 510(k) clearance for epicardial ablation, the Montreal company announces May 8. Until the company's clinical advisory board completes a comprehensive dissemination plan later this year, the device will be targeted to operators familiar with the epicardial arrhythmia ablation technique pioneered by Eduardo Sosa, MD, University of Sao Paulo. On April 22, Freezor was approved for treating atrioventricular node re-entry tachycardia (1"The Gray Sheet" May 5, 2003, In Brief)...

Keeping Track: Cancer Approvals From Lumisight Imaging To Adjuvant Alecensa

The US FDA’s approval of Lumicell’s optical imaging agent Lumisight makes a dozen novel approvals in 2024 for the Center for Drug Evaluation and Research.

Partisan Politics Returns To US FDA Congressional Oversight

The US FDA has stood out as an agency that tends to draw broad bipartisan support amid a generally rancorous and divided Congress. A House hearing, however, may be a sign that those days are over.

Latest Headlines
See All
UsernamePublicRestriction

Register

MT018313

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