Thoratec, HeartMate PHP. CE Mark approval, SHIELD I

Thoratec announced that the HeartMate PHP (Percutaneous Heart Pump) received CE Mark approval, permitting sale in the European Union and other international countries. Approval was based on data from the first 30 patients enrolled in the HeartMate PHP SHIELD I CE Mark Trial examining use of PHP to support patients undergoing a high-risk percutaneous coronary intervention (PCI) procedure. Data from all 50 patients enrolled in this study will be presented later in 2015.

Biotronik announced the completion of the BIOVALVE first-in-human trial for its new transcatheter aortic valve. Study doctors successfully implanted the device in patients suffering from severe symptomatic aortic stenosis. The study, which established the transcatheter aortic valve implantation (TAVI) device's early safety at 30 days, was conducted at the University Heart Center Hamburg-Eppendorf (UKE), Germany.

Mindray announced the release of its TE7 Touch Enabled Ultrasound System, which supports rapid and confident evaluation in multiple point-of-care (POC) settings. The intuitive tablet-like operation, high image quality with one-touch image optimization, and exam presets improve both diagnostic confidence and efficiency.

On July 8, the Centers for Medicare and Medicaid Services (CMS) released the first proposed update to the physician payment schedule since the repeal of the Sustainable Growth Rate in April. The proposal includes a number of provisions focused on person-centered care, and continues the Obama administration’s commitment to transform the Medicare program to a system based on quality and healthy outcomes.

Rivanna Medical announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance to market Accuro, a handheld and untethered smart phone-sized ultrasound device. Accuro is designed to guide spinal anesthesia with automated 3-D navigation technology in addition to ultrasound imaging of abdominal, musculoskeletal, cardiac and peripheral vascular anatomies.

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