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


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)...

Hanmi And LG Chem Highlight Vaccine Prowess, Novel R&D At JPM

Hanmi showcases at JPM its contract production capabilities for COVID-19 vaccines as South Korea prepares to bring in candidates from several global developers, while LG Chem highlights progress across multiple pipeline projects.

Keeping Track: Submissions Galore Start The New Year; US FDA Clears New Indications For Enhertu, Xalkori

The latest drug development news and highlights from the Pink Sheet US FDA Performance Tracker




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