CardiacAssist said today it won FDA 510(k) clearance for its TandemLung oxygenator designed to operate as an artificial lung by infusing oxygen and removing carbon dioxide from the blood. The Pittsburgh, Penn.-based company said the TandemLung is designed so it can be used along with its TandemHeart blood pump, and combined the devices “represent a leap […]
CardiacAssist last week said it nailed down CE Mark approval in the European Union for a cannula designed to both drain and re-infuse blood during life support procedures.
Pennsylvania-based CardiacAssist landed in the FDA’s cross hairs this month after agency inspectors found that the company failed to file a report after learning of a patient death.
Pittsburgh-based medical device maker CardiacAssist received Investigational Device Exemption approval from the FDA to begin a pivotal clinical study of its TandemHeart circulatory support system.
The TandemHeart to Reduce Infarct Size trial will evaluate the effectiveness of ventricular unloading on the reduction of infarct size for patients with severe heart attack, according to the press release.