Outset Medical (NSDQ:OM) announced that it appointed Edwards Lifesciences executive Katie Szyman to its board of directors. Szyman currently serves as corporate VP & GM of critical care at Edwards, having spent more than 30 years in leadership roles in the medtech space, according to a news release. Much of her experience came in 23 […]
Dialysis
Outset Medical sales more than triple in Q1
Outset Medical (NSDQ:OM) posted first-quarter results that beat the overall consensus on Wall Street and increased its guidance. The San Jose, Calif.-based Tablo dialysis machine maker reported losses of -$30 million, or -70¢ per share, on sales of $22.9 million for the three months ended March 31, for a sales growth of 218.72% compared with […]
Vascular Therapies touts surgical stenosis treatment trial despite missed primary endpoint
Vascular Therapies announced today that a Phase 3 clinical trial of its Sirogen sirolimus formulation showed encouraging outcomes. Cresskill, N.J.-based Vascular Therapies designed its Sirogen proprietary sirolimus formulation for intraoperative local drug delivery to reduce surgical stenosis in blood vessels. The Phase 3 clinical trial evaluated Sirogen in elderly end-stage renal disease patients, according to a […]
BD lands FDA clearance for hemodialysis catheter
BD (NYSE:BDX) this week said it has received FDA 510(k) clearance for its Pristine long-term hemodialysis catheter. The catheter has a side-hole free symmetric Y-tip distal lumen design that is designed to minimize thrombus adhesion and help facilitate blood clot aspiration prior to hemodialysis treatment. Its symmetric tip is designed to help minimize recirculation rates […]
Outset Medical closes $149.7M public offering
Outset Medical (NSDQ:OM) announced that it closed a previously announced underwritten public offering with proceeds of approximately $149.7 million. San Jose, Calif.–based Outset offered 2.9 million shares of common stock sold by the company itself, plus nearly 3.9 million shares of its common stock sold by certain stockholders at a public offering price of $53.50 per […]
Outset Medical to raise nearly $366M from primary, upsized offerings
Outset Medical (NSDQ:OM) announced today that it priced an underwritten public offering of shares of its common stock. San Jose, Calif.–based Outset — maker of the Tablo hemodialysis system — is offering 2.5 million shares of common stock sold by the company itself, plus more than 3.4 million shares of its common stock sold by […]
Fresenius to provide more home dialysis machines to DaVita
Fresenius Medical Care North America (FMCNA) has expanded its agreement with DaVita Kidney Care to provide NxStage home hemodialysis machines and related technology to DaVita’s U.S. patients. “We are excited to expand our longstanding collaboration with DaVita to help more patients benefit from the portability, dependability, and flexibility of our NxStage home machines, which are […]
CMS delays shift to new payment model for chronic kidney disease treatments
CMS will now wait until Jan. 1, 2022 to start its Kidney Care Choices model, meant to shift the way the U.S. treats chronic kidney disease. The new payment model was supposed to start on Jan. 1 of this year, but health providers are still grappling with the COVID-19 pandemic. The new model could have […]
Baxter wins FDA clearance for AK 98 hemodialysis machine
Baxter (NYSE:BAX) announced today that it recieved FDA clearance for its next-generation artificial kidney 98 (AK 98) dialysis machine. Deerfield, Ill.-based Baxter’s AK 98 machine is designed as a portable and easy-to-use system to administer hemodialysis (HD) treatments. It offers encrypted, two-way connectivity to enable the system to pull prescriptions directly from the electronic medical record […]
Medtronic launches DCB for dialysis patients in Japan
Medtronic (NYSE:MDT) this week said it launched its first drug-coated balloon in Japan for patients undergoing hemodialysis. The company launched its In.Pact AV drug-coated balloon, which is indicated for the treatment of obstructive lesions up to 100 mm in length in the native arteriovenous dialysis fistulae in patients with end-stage renal disease and undergoing hemodialysis. It […]
Medtronic launches pediatric blood-filtering device in U.S.
Medtronic (NYSE:MDT) announced today that it launched its Carpediem cardio-renal pediatric dialysis emergency machine in the U.S. Fridley, Minn.-based Medtronic’s Carpediem machine received FDA de novo clearance in May for providing continuous dialysis in critically ill young children. The first-of-its-kind machine is indicated for use in acute kidney injury or fluid-overloaded patients requiring hemodialyiss or hemofiltration […]
