A Diagnostics & Imaging Week

EP MedSystems (West Berlin, New Jersey) reported executing a settlement with the Bureau of Industry and Security of the U.S. Department of Commerce to close issues related to its shipment of products to restricted countries in 2004 and earlier.

The company does not admit or deny guilt, but agrees to pay a fine of $244,000 with no restrictions on commercial or export activities. The company said it has accrued $345,000 for this penalty in its books as of June 30.

The company also said that it has made a settlement offer to the U.S. Department of the Treasury in connection with an investigation of these shipments and is awaiting a response. It said the Treasury Department has indicated to it "orally" that the maximum penalty it might seek would be $44,000.

Given that any investigations by the Treasury Department or the Securities and Exchange Commission have not been closed, the company said it could not rule out additional civil or administrative penalties since the investigations have not been closed. But it said it has made no provision for any future costs associated with these investigations or any costs associated with the "defense or negotiations" to resolve any outstanding issues.

David Bruce, new president/CEO of EP MedSystems, said, "We continue to cooperate with the other governmental entities in hopes that we can close any remaining issues as quickly as possible. "

EP MedSystems develops cardiac electrophysiology (EP) products used to diagnose and treat certain cardiac rhythm disorders.