The FDA’s Circulatory System Devices Panel will in October reconsider CardioMEMs’ once-rejected application for its Champion heart failure monitoring system, a potential boon for stakeholder St. Jude Medical.
Once-rejected CardioMEMs will get another shot at FDA approval for its Champion implantable heart failure monitoring systems when the agency’s Circulatory System Devices Panel convenes next month, according to a notice in the Federal Register.
That means a 2nd chance for a company previously considered “dead in the water,” according to analysts at Leerink Swann, as well as a potential boon for CardioMEMs backer St. Jude Medical (NYSE:STJ).
