Earlier this year the fate of Surmodics' SurVeil CE mark submission was unclear as European regulators temporarily halted review of new paclitaxel devices. The tide has apparently turned, however, because the drug-coated balloon is now CE marked.
The proposed merger comes at a time when many companies have backed away from deals because of the COVID-19 pandemic.
Abiomed said it was granted Emergency Use Authorization for the Impella RP to include patients suffering from COVID-19 related right heart failure or decompensation, including pulmonary embolism. The Danvers, MA-based company initially received...
The Dublin-based company is recalling the HeartWare HVAD pump outflow graft and outflow graft strain relief because of the risk of breaks and tears during the pre-implant pump assembly process. FDA has identified this as a Class I recall.
The Seattle, WA-based company also won CE mark for a 14-day version of the Carnation Ambulatory Monitor.
The Irvine, CA-based company said its Pascal System has not yet been approved in the U.S.
The Danvers, MA-based company also posted results that beat Wall Street expectations.
Portland, OR-based VisCardia is developing VisOne, an implantable system that delivers synchronized diaphragmatic stimulation (SDS) therapy for improving cardiac function.
Rehovot, Israel-based Pi-Cardia has raised $27 million to help establish the efficacy and long-term safety of its Leaflex Catheter.