The FDA today said its recall of a select number of SynCardia Systems Total Artificial Heart Freedom driver is Class I. A Class I recall is the most serious type of recall issued by the federal watchdog, which indicates “there is a reasonable probability that use of these products will cause serious adverse health consequences or death.” […]
SynCardia
SynCardia sets terms for $28m IPO
SynCardia Systems today set the terms for its pending initial public offering, saying it plans to float 2.5 million shares at $10 to $12 apiece. That works out to a range of $25 million to $30 million, $27.5 million at the midpoint. Tucson-based SynCardia estimated that the IPO could raise as much as $40 million when […]
Artificial heart maker Syncardia preps $40m IPO
SynCardia Systems yesterday registered for an initial public offering worth up to $40 million, making it the 2nd medical device company in as many weeks to file for an IPO. SynCardia, which makes an artificial heart system designed to replace the functions of both the left and right ventricles and all 4 heart valves, said it plans to […]
SynCardia warns on artificial heart driver
SynCardia Systems sent a letter to surgeons yesterday warning them about issues with a component of its artificial heart in patients who received pre-implant circulatory rescue interventions. The letter concerns Syncardia’s Total Artificial Heart Companion 2 Driver system. SynCardia won FDA approval for the C2 system in 2012 as a smaller replacement for the CSS console, which won […]
FDA OKs SynCardia trial for bridge-to-transplant indication
SynCardia Systems said today that it won FDA approval for a clinical trial of its artificial heart as a bridge to transplant for patients with heart failure.
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Press Release: FDA approves the Syncardia total artificial heart with Synhall valves
SynCardia lands key FDA win for its Total Artificial Heart
Arizona-based SynCardia Systems announced this week that it won FDA approval for its SynHall valves, which the company called "the last key component to manufacture the Total Artificial Heart."
Press Release: FDA approves the freedom portable driver that powers the SynCardia total artificial heart
FDA win lets SynCardia artificial heart patients out of the hospital
Artificial heart maker SynCardia announced this week that it won FDA approval for its Freedom driver, a portable power driver that allows patients to take their artificial heart systems out of the hospital.
