Cardima PMA revisited
This article was originally published in The Gray Sheet
Executive Summary
Maker of the Revelation Tx atrial fibrillation catheter plans to meet with FDA to discuss steps the company should take to earn PMA approval. On May 29, FDA's Circulatory System Devices panel voted that Cardima's study of 83 patients with drug-refractory, paroxysmal AF was inadequate to support PMA approval of the device (1"The Gray Sheet" June 2, 2003, p. 3). Cardima said it is reviewing a transcript of the meeting...
You may also be interested in...
Cardima in Europe
Revelation Helix STX, the "large loop" version of Revelation Helix, features 16 3 mm electrodes for better tissue contact in treating atrial fibrillation in patients with larger pulmonary veins, according to the Fremont, Calif. company. Helix STX is the fifth product in the Revelation line to receive European CE mark authorization, the company announces July 10. Cardima is in discussions with FDA on how to revive a PMA for the Revelation Tx, following a negative advisory panel review in May (1"The Gray Sheet" June 23, 2003, In Brief)...
Cardima’s Revelation: AF Self-Monitoring, Hazy Endpoints Hamper Review
The ability of self-reporting to accurately track reduction in atrial fibrillation burden is cast into doubt by FDA panel experience with Cardima's Revelation ablation system data submission
Atlas Biomed Unlocking Japan’s OTC Market With Direct-To-Consumer DNA And Microbiome Tests
Can Atlas Biomed unlock Japan's self-care market with its direct-to-consumer DNA and microbiome tests? HBW Insight catches up with the company's co-founder and CEO to discuss this and also how Atlas has been driving its European expansion plans despite coronavirus.
Need a specific report? 1000+ reports available
Buy Reports
Register for our free email digests: