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.
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.