EP MedSystems seeks 510(k) for integrated system

AuntMinnie.com staff writers
Jul 23, 2003

Electrophysiology device developer EP MedSystems has requested a 510(k) regulatory clearance filing with the Food and Drug Administration for the integration of its EP-WorkMate electrophysiology workstation with Boston Scientific’s Realtime Position Management technology.

The integrated system will allow physicians to combine real-time position, navigation, and advanced mapping features with recording and patient management capabilities, according to the West Berlin, NJ-based firm.

The firm also said that it had formed an alliance with the electrophysiology business unit of Natick, MA-based Boston Scientific under which EP MedSystems will market and distribute the integrated product, to be known as the EP-WorkMate with RPM.

By AuntMinnie.com staff writers
July 24, 2003

Related Reading

EP MedSystems gets CE Mark, May 2, 2003

EP MedSystems files 510(k) for ultrasound catheter system, April 4, 2003

EP MedSystems files for CE Mark, January 3, 2003

EP MedSystems, EchoCath bury hatchet, January 8, 2002

EPMD to distribute Fischer fluoro units, May 9, 2001

Copyright © 2003 AuntMinnie.com

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