Founded and led by serial entrepreneur Amr Salahieh, Apama Medical is developing a system that aims to combine the advantages of two approaches for treating atrial fibrillation: point-by-point radiofrequency-based ablation and cryoballoon ablation.
The goal of a new atrial fibrillation (AF) catheter ablation system from Apama Medical Inc. is to bridge the gap that exists today between point-by-point ablation and cryoballoon ablation.
The standard and historic solution for treating AF is to use a radiofrequency (RF)-irrigated catheter with an electrode tip that...
Two recent recalls from the US FDA involve three deaths linked to an issue with an Abiomed heart pump — as well as three serious injuries related to angiographic catheters from Cook Medical.
Dexcom’s CEO Kevin Sayer discusses this fall’s planned launch of the 15-day G7 CGM, downplays Abbott’s dual-sensor while focusing on development of multi-analyte G8, making OTC Stelo app more “consumerish” for Europeans, and more.
The FDA has released draft guidance clarifying UDI rules for drug- and device-led combination products. The document specifies labeling requirements and makes recommendations to reduce confusion between UDIs and NDCs. Comments are being accepted until Sept. 24.
