Lausanne, Switzerland-based Debiotech SA and Neokidney BV, of Amsterdam, have created Nextkidney SA to lead the development and commercialization of Neokidney, a lightweight, plug-and-play, home hemodialysis device.

With the COVID-19 pandemic overwhelming hospitals and treatment centers, San Jose, Calif.-based Outset Medical Inc. scored a big win with U.S. FDA clearance of its Tablo hemodialysis system for home dialysis use. The company will begin rolling the system out for home patients in the coming months, balancing that program with demand for onsite devices to support an upswell in COVID-driven dialysis treatments.

San Francisco-based startup Cloudcath has raised a $12 million series A round to support commercialization of its first product that enables remote, real-time monitoring for at-home peritoneal dialysis patients. The expectation is that the notifications it offers to health care providers will enable earlier intervention to avoid complications, including infection. The Cloudcath system is pending U.S. FDA clearance.

Roseville, Calif.-based US Kidney Research Corp., formerly Curion Research Corp., has been working on its waterless renal replacement technology since its inception in June 2015. Its latest research efforts using its novel blood purifying technology have led to the production of the first ‘synthetic urine,’ which mimics the body’s natural production and the kidney’s filtration capability.

The U.S. FDA has given Medtronic plc a green light for its In.Pact AV drug-coated balloon, the second application for the Dublin-based company’s In.Pact DCB platform. The paclitaxel-coated balloon is now indicated for the treatment failing arteriovenous (AV) access in patients undergoing dialysis due to end-stage renal disease (ESRD). In.Pact AV leverages technology from Medtronic’s In.Pact Admiral DCB, which first snagged FDA approval in 2015 for treatment of superficial femoral artery (SFA) lesions above the knee.

San Clemente, Calif.-based ICU Medical Inc. has acquired Minneapolis-based Pursuit Vascular Inc. for $75 million and an additional, undisclosed earn-out payment that would be due in 2021. In the deal, it gains the Clearguard HD Antimicrobial Barrier Cap, which is the only U.S.-marketed device that's been shown to reduce central line-associated bloodstream infections in hemodialysis patients.

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.