Direct Flow Medical wins CE Mark approval in the European Union for the smallest size of its replacement heart valve and another EU nod for implanting the device without contrast media.
Direct Flow Medical said today that it won CE Mark approval in the European Union for an additional size of its replacement heart valve, plus an EU OK for the use of the devices without contrast media.
Cook Medical says it's begun enrollment in a clinical trial in China for its Zilver PTX peripheral stent.
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.
AdvancedCath opens a new facility to make guidewires, catheters and components for its OEM clients.
AdvancedCath said it's opening a new, 20,000-square-foot facility in Costa Rica to make its line of catheters and components for OEM customers.
Zoll Medical lands Shonin approval in Japan for its Series R combination monitor and automated external defibrillator.
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.
Medtronic and Lifetech Scientific expand their deal to co-produce pacemakers for the Chinese market.
Merit Medical says the Chinese FDA granted approval for its Aero tracheobronchial stent, marking its Endotek division's 1st entry into the People's Republic.
More than 2 years after inking a $22 million deal to settle charges that it violated the Foreign Corrupt Practices Act, Biomet says the SEC issued a subpoena over alleged "improprieties" in Brazil and Mexico.