Electrophysiology device developer EP MedSystems of West Berlin, NJ, said it intends to file a request for premarket approval with the Food and Drug Administration for its Alert CS/RA catheter system.
The product replaces existing electrophysiology catheters, allowing routine diagnostic procedures and the capability to internally cardiovert atrial fibrillation to normal heart rhythm during the procedure, according to the company.
Pending FDA approval, the firm said it anticipates launching the product in the U.S. during the first quarter of 2006.
By AuntMinnie.com staff writers
May 31, 2005
Related Reading
EP MedSystems initiates ICE-CHIP trial, May 4, 2005
EP MedSystems boosts sales, trims losses in 2004, March 11, 2005
EP MedSystems nets $4.5 million, December 16, 2004
EP MedSystems posts robust Q3, October 27, 2004
EP MedSystems gets CE Mark, July 27, 2004
Copyright © 2005 AuntMinnie.com
