NxStage wins CE Mark for next-gen System One hemodialysis system

NxStage Medical (NSDQ:NXTM) said today it won CE Mark approval in the European Union for its next-gen System One hemodialysis system. The newly cleared system incldues a new touchscreen user interface and integrated blood pressure montior designed to enhance ease of use for home hemodialysis patients, the Lawrence, Mass.-based company said. “Our next generation system was developed with extensive patient and customer feedback and builds on our decade long experience in providing life-changing therapy with the NxStage System One to over 30 thousand patients in their homes around the world. We are very excited to expand our portfolio and begin providing patients with new features and capabilities that are designed to significantly improve their therapy experience,” prez Joseph Turk said in a press release. The company said the device is currently under review for FDA 510(k) clearance. On Wednesday, NxStage Medical saw shares rise after the medical device maker met expectations on Wall Street with its 4th quarter and full year 2016 earnings results, rising 2.6% to close at $29.29. The company posted losses of $2.4 million, or 2¢ per share on sales of $93 million for the 3 months ended Dec. 21, seeing bottom-line losses shrink 13.6% while sales grew 3.6% compared with the same period last year. Earnings per share were exactly on target with expectations on The Street, where analysts were expecting to see sales of $91.8 million. NxStage said it expects to post sale...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Business/Financial News Regulatory/Compliance NxStage Medical Inc. Source Type: news