NxStage Medical (NSDQ:NXTM) said today it won FDA 510(k) clearance for its next generation System One hemodialysis system.
The newly cleared system includes a new touchscreen user interface and integrated blood pressure monitor designed to enhance ease of use for home hemodialysis patients, the Lawrence, Mass.-based company said.
“Early customer and patient feedback in the UK on our next generation system has been very positive, validating many of the benefits we expected. We are very excited to bring these new features and capabilities that are designed to significantly improve our patients’ therapy experience to the US market. The touch screen interface provides an excellent platform to continue bringing new features and functionality moving forward,” prez Joseph Turk said in a prepared statement.
Yesterday, NxStage met the consensus forecast for its 1st-quarter earnings and topped the revenue expectation on Wall Street.
The dialysis device maker narrowed its losses by -6.8% to -$1.2 million, or -2¢ per share, on sales of $96.8 million for the 3 months ended March 31, for top-line growth of 8.5% compared with Q1 2016. Analysts on The Street were looking for losses of -2¢ on sales of $95.3 million.