Fist Assist Devices LLC received a breakthrough device designation from the FDA for its Fist Assist Model FA-1 device for patients with end-stage renal disease (ESRD). The pre-surgical dilation device promotes arteriovenous (AV) fistula creation in renal failure patients with inadequate vein size for creation of an AV fistula for hemodialysis. An AV fistula is a surgical connection between an artery and a vein used as an access point for dialysis.

The U.S. Center for Medicare & Medicaid Services (CMS) has made the first award to a product under an add-on payment for treatment of end-stage renal disease (ESRD) as part of the prospective payment schedule for calendar year 2022. Outset Medical Inc., of San Jose, Calif., snared the first of these novel add-on payments for medical technologies under the ESRD prospective payment system, but device makers working the ESRD space can expect to see many similar such awards in the years ahead.

The FDA has designated Impedimed Ltd.’s Sozo digital health platform a breakthrough device for renal failure, paving the way for the first FDA approved device to measure fluid volume in the dialysis setting.

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.

PERTH, Australia – About seven years ago, Australia’s George Institute for Global Health conducted a study to find out how many people require dialysis for end-stage kidney failure compared to how many people receive treatment.

Patensee Ltd. initiated a first-in-human trial of its machine vision-based surveillance system for stenosis in hemodialysis patients. The trial will evaluate the imaging system's ability to perform contact-free surveillance of the access points or fistulas essential for dialysis, which nearly all narrow or become blocked over time. The surveillance system aims to mimic the central components of a dialysis nurse's exam using technology.

Diagnostics innovator Renalytix AI plc and dialysis giant Davita Inc. partnered to develop a program to identify individuals with early-stage kidney disease and improve outcomes for the 37 million Americans with chronic kidney disease (CKD). The companies plan to launch the collaborative effort in three cities in 2021 to build a diverse, real-world evidence dataset as a base for moving forward.

Critically ill infants in need of continuous renal replacement therapy (CRRT) are often treated using machines intended for adults, leading to a number of challenges and a high risk of complications and death. Now, Medtronic plc has launched a pediatric and neonatal acute dialysis machine in the U.S. that is specifically designed for patients weighing between 2.5 and 10 kilograms. The Carpediem Cardio-Renal Pediatric Dialysis Emergency Machine, the first of its kind in the U.S., received U.S. FDA clearance in April via the de novo pathway and is classified as a class II device.

PERTH, Australia – Astrazeneca plc is leasing 175 Sozo devices from Impedimed Ltd. and plans to put them in 20 countries to run phase II trials for a combination drug that looks at fluid imbalance in the human body in patients with heart failure (HF) and chronic kidney disease.