HeartWare touts expanded CE Mark approval for long-term use of its implantable heart pumps
HeartWare International (NSDQ:HTWR) won expanded CE Mark approval in the European Union to market its HeartWare ventricular assist system for long-term use in all patients at risk of refractory, end-stage heart failure.
The indication is similar to the "destination therapy" indication HeartWare is seeking in the U.S., where the company recently completed enrollment in a 450-patient clinical trial. The device originally won CE Mark in 2009.
HTWR shares were trading up 0.3% to $78.46 as of about 3:45 p.m. today.
ActiViews lands Chinese regulatory approval for its CT-Guide needle guidance system
ActiViews announced approval from China’s State Food & Drug Administration for its CT-Guide navigation system, designed to provide real-time location of interventional instruments and the trajectory to target during CT-guided procedures.
CardioComm wins FDA clearance for HeartCheck ECG pen
CardioComm Solutions (CVE: EKG) announced 510(k) clearance for its HeartCheck ECG pen for prescription use physicians in screening and monitoring of arrhythmias and sudden death prevention efforts.