Cook Medical said it enrolled the 1st patient in a 1st-of-its-kind clinical trial in China for its Zilver PTX drug-eluting peripheral stent as it looks to win approval for the device in the People’s Republic.
Zoll Medical said today that it won Shonin approval from the Japanese Ministry of Health, Labor & Welfare for its R Series combination monitor and automated external defibrillator.
The U.S. Securities & Exchange Commission closed its review of Medtronic’s sales to strife-torn Syria and Sudan and to Cuba, which the medical device company said are made on a humanitarian basis and amount to a small fraction of its total business.
The SEC asked Medtronic in January to explain its business contacts in the 3 nations, which are flagged as state sponsors of terrorism and are subject to U.S. economic sanctions and assets controls.
By Randy Stpehens and Mary Bennett
Smart device manufacturers implement compliance programs to minimize the risk of corruption through policies, hotlines, training and auditing. However, such controls are largely aimed at shaping the behavior of their employees. What about agents, distributors and other third party partners? After all, the GlaxoSmithKline corruption scandal allegedly involved the use of travel agencies1. What about third parties acting on their own, yet on behalf of a medical device firm?