PARIS – Vygon SA, of Ecouen, France, has acquired Advanced Perfusion Diagnostics SA (APD), a startup based in Lyon, France, that has developed Ikorus, a device that detects changes in visceral microvascular blood flow in the most critically ill hospital patients. Vygon did not disclose the financial details behind the agreement.

The U.S. FDA has given its nod to Novalung, a heart and lung support system from Fresenius Medical Care North America (FMCNA) for the treatment of acute respiratory or cardiopulmonary failure. The Waltham, Mass.-based company noted that Novalung is the first extracorporeal membrane oxygenation (ECMO) system to be cleared for more than six hours of use.

NATIONAL HARBOR, Md. – Berlin-based Biotronik SE & Co. reported new data from the BIOFLOW-V trial showing that its Orsiro ultrathin strut drug-eluting stent (DES) continued to outperform Abbott Laboratories’ Xience DES through three years’ follow-up.

NATIONAL HARBOR, Md. – Cardiovalve Ltd., of Or Yehuda, Israel, scored a double hit with the U.S. FDA, winning a breakthrough device designation for its transcatheter tricuspid valve replacement system, as well as approval to conduct an early feasibility study in tricuspid regurgitation (TR).

Acutus Medical Inc. is working to build itself into a major competitor in cardiac electrophysiology. The latest step to do so is an FDA clearance for its second-generation cardiac mapping software known as Supermap. This works in conjunction with its next-gen Acqmap 3D Imaging and Mapping System. The Carlsbad, Calif.-based startup, which was founded in 2011, is now marketing these in both the U.S. and Europe, where Supermap received a CE mark in October 2019.

Medtronic plc, of Dublin, blamed dampened demand for heart devices ahead of new product launches for its third-quarter revenue miss. Fiscal 2020 Q3 revenue totaled $7.72 billion, below Wall Street’s estimate of $7.81 billion, for organic sales growth of 2.6% vs. consensus and guidance of 4% or higher.

Brisbane, Calif.-based Caption Health Inc. received good news from the U.S. FDA, which has given a thumbs up to Caption Guidance. This software aims to assist medical professionals in the acquisition of cardiac ultrasound images and uses artificial intelligence (AI) to provide real-time guidance.