Awak Technologies announced today that it raised $20 million in Series B funding to support its dialysis technology. The Singapore-based company designed Awak PD as a wearable and ultraportable peritoneal dialysis (PD) system. It offers patients the freedom to undergo dialysis at home and anywhere on the go. It helps to overcome the challenge of […]
Dialysis
FDA clears software for Fresenius home hemodialysis system
Fresenius Medical Care announced today that the FDA granted 510(k) clearance for its Versi HD with GuideMe software. The completely reinvented, self-guided interface serves Fresenius’ VersiHD chronic home hemodialysis (HHD) system. It aims to transform the experience of HHD for both patients and nurses. Fresenius Medical Care’s NxStage designed VersiHD with GuideMe to provide graphical […]
Teleflex extends Arrow ErgoPack system with hemodialysis, large bore catheters
Teleflex announced today that it released its Arrow ErgoPack complete kits with hemodialysis and larbe bore catheters in the U.S. Wayne, Pennsylvania-based Teleflex launched this update to streamline insertion workflow for clinicians. The company also says it provides more options to suit their particular needs. Get the full story at our sister site, Medical Tubing […]
Outset Medical pauses shipments for Tablo accessory as it awaits FDA clearance, stock sinks
Outset Medical shares took a hit after the at-home dialysis tech company announced a shipment hold within its second-quarter results. Shares of OM fell 12.7% at $16.91 apiece in after-hours trading after the release of the news yesterday evening. By midday today, OM shares had recovered slightly, down more than 10% to $17.27 apiece MassDevice‘s […]
Fresenius Medical Care stock dips on mixed Q2 results
Fresenius Medical Care shares fell this morning on second-quarter results that came in mixed compared to the consensus forecast. Shares of FMS were down 2% at $25.33 apiece in early-morning trading today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — fell by nearly 1%. The Germany-based dialysis […]
Baxter names proposed kidney care spinoff ‘Vantive’
Baxter announced today that it picked “Vantive” as the name of its proposed kidney care spinoff. In January, Baxter announced plans to spin its renal care and acute therapies units into an independent, publicly traded company. It said at the time that it expected the company to stand alone in the next 12 to 18 […]
Fresenius Medical Care converts to German stock corporation to simplify corporate structure
Fresenius Medical Care announced today that an Extraordinary General Meeting (EGM) saw shareholders approve a change to corporate structure. The renal disease treatment product provider’s shareholders approved all EGM agenda meetings with a large majority. One major approval was the conversion of Fresenius Medical Care from the legal from of a partnership limited by shares […]
Fresenius Medical Care appoints new CFO
Fresenius Medical Care announced today that it appointed Martin Fischer as its new chief financial officer (CFO). Fischer’s appointment goes into effect on Oct. 1, 2023. He succeeds Helen Giza, who took over as CEO and board chair in December 2022. She took on the corner office after CEO Carla Kriwet decided to leave the […]
Outset Medical stock sinks after it receives FDA warning letter
Outset Medical announced that it received a warning letter from the FDA related to its Tablo system. San Jose, California-based Outset previously disclosed an FDA Form 483 in its annual report in February. That FDA form identified four inspectional observations resulting from an inspection concluded on Feb. 10, 2023. From there, Outset provided a response […]
Merit Medical spends $132.5M on acquisitions to expand its offerings
AngioDynamics (Nasdaq:ANGO) announced that it completed the sale of its dialysis product portfolio to Merit Medical Systems. It was part of a series of product acquisitions worth $132.5 million that Merit (Nasdaq: MMSI) has announced. Latham, New York-based AngioDynamics sold its dialysis portfolio and the BioSentry product for $100 million in cash. The transaction includes […]
Outset Medical upgrades full-year guidance after strong Q1 performance
Outset Medical this week posted first-quarter results that beat the overall consensus on Wall Street. The San Jose, California-based dialysis company reported profit losses of $43.97 million, or 90¢ per share, on sales of $33.5 million, for the three months ended March 31, for a sales gain of 9.55% compared to Q1 2022. It had […]
