Berlin – Fresenius SE & Co. KGaA reported that its global division, Fresenius Medical Care, and its Frenova Renal Research division have enrolled the first subjects in its new initiative to develop the largest genomic registry in the world to focus on kidney disease. At the same time, the German firm also announced that Ali Gharavi, chief of the division of nephrology at Columbia University Irving Medical Center, will lead the project and provide scientific guidance as principal investigator.

After a long approval process, Monmouth Junction N.J.-based Cytosorbents Corp. received clearance to bring its Cytosorb blood purification technology to treat cytokine storm and deadly inflammation in critically ill and cardiac surgery patients, to the Mexican market. The COVID-19 pandemic may delay marketing plans to roll-out the product in the Latin American country.

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.

Biointellisense Inc. received good news from the U.S. FDA, which gave its nod to the company’s Biosticker on-body sensor for scalable remote care. The Biosticker allows for continuous monitoring of vital signs and actionable insights, delivered to clinicians from patients in the home setting. The goal is to help in the early detection of potentially avoidable complications.

The U.S. FDA has granted a breakthrough device designation for a new hemodialysis system from Fresenius Medical Care Holdings Inc. The device is designed to prevent blood blotting without the use of blood-thinning medication, such as heparin, that most dialysis patients require.