Topic: CardioMEMS Inc.
WASHINGTON (Reuters) - A U.S. Food and Drug Administration panel on Thursday decided not to recommend CardioMEMS implantable heart device for treating heart failure because supporting clinical research appeared biased by human intervention.Six out of 10 members of the FDA advisory committee ...
WASHINGTON (Reuters) - U.S. health regulators on Monday said a CardioMEMs implant for treating heart failure met its main safety and effectiveness targets but warned of potential bias in the company's research.A Food and Drug Administration staff review of the CardioMEMS Champion ...
WASHINGTON (Reuters) - A Food and Drug Administration review of CardioMEMS' device for treating heart failure found it has met its main safety and effectiveness goals, based on trial results.But the FDA questioned on Monday how clinically significant the findings are for ...
