News

Aug. 8, 2012 — The Berlin Heart Group said the U.S. Food and Drug Administration (FDA) has granted approval for its post approval study, a condition of the humanitarian device...

July 3, 2012 — Patients unable to breathe because of acute lung failure or an obstructed airway need another way to get oxygen to their blood—and fast—to avoid cardiac arrest and brain injury. A...

June 14, 2012 — Abiomed Inc. said today it received Health Canada approval to market the Impella cVAD (...

 

May 21, 2012 — Minnetronix announced the exclusive licensing rights of Penn State Research Foundation’s wireless energy transmission technology to power circulatory assist...

May 16, 2012 — Maquet Cardiovascular LLC announced this week that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its new Mega 7.5 Fr. 30 cc and 40 cc...

April 23, 2012 - CircuLite Inc. announced that updated clinical data related to the Synergy miniature ventricular support system was presented in two oral presentations and one poster session at...

April 17, 2012 – SynCardia Systems Inc., manufacturer of the world’s first and only FDA-, Health Canada- and CE-approved Total Artificial Heart, announced that the U.S. Food and Drug...

April 12, 2012 - Abiomed Inc., a provider of heart support technologies, announced it has received CE marking approval in the European Union to market the Impella cVAD device, a new percutaneous...

April 9, 2012 — Thoratec and the U.S. Food and Drug Adminstration (FDA) announced a recent Class 1 recall of the HeartMate II left ventricular assist device (LVAD) because detachment of the bend...

March 26, 2012 — Maquet announced positive long-term mortality results from the Balloon Pump-Assisted Coronary Intervention Study (BCIS-1), which evaluated the effect on major complications and...

Jack Miller, 62, is probably the only politician in America who smiles when people call him “heartless.” Four months ago, doctors at Virginia Commonwealth University (VCU) Medical Center in...

March 5, 2012 — SynCardia Systems Inc., manufacturer of the world’s first and only U.S. Food and Drug Administration (FDA), Health Canada and Conformité Européenne (CE) approved Total Artificial...

Jarvik Heart Inc. announced conditional U.S. Food and Drug Administration (FDA) approval of its pivotal trial for evaluation of the Jarvik 2000 heart for destination therapy (DT). Use of the...

Teleflex Inc. announced a new agreement with HealthTrust Purchasing Group L.P. (HealthTrust), for its Arrow Intra-Aortic Balloon Pump and Catheter products. The new agreement begins March 1, 2012...

February 22, 2012 — HeartWare International Inc. announced that a U.S. Food and Drug Administration (FDA) Circulatory System Devices Panel will review the premarket approval (PMA) application for...

February 16, 2012 — Few hospitals have as much experience with the Berlin Heart pediatric ventricular assist device (VAD) as DMC Children's Hospital of Michigan. This is why the U.S. Food and Drug...

Symphony.

February 2, 2012 — Abiomed Inc. announced that initial clinical data from the safety study for Symphony was presented by Renzo Cecere, M.D., FRCSC, FACS, associate professor of surgery at McGill...

January 27, 2012 — A miniature, battery-free, wireless, cardiac implant being developed by a University of Michigan researcher and the Ann Arbor, Mich., company Integrated Sensing Systems, Inc. (...

January 11, 2012 — HeartWare International, Inc. and Dualis MedTech GmbH, a subsidiary of AVRA Surgical, Inc., announced an agreement to develop ventricular assist devices with wireless,...

December 19, 2011— Newborns, toddlers and teens who suffer from heart failure and need heart transplantation to survive just got a life-saving pediatric heart pump that buys time and allows them...