Fysicon, the Dutch developer and manufacturer of medical solutions, is proud to announce that it has been granted 510(k) clearance by the US Food and Drug Administration for its QMAPP hemodynamic monitoring system.
QMAPP offers cardiologists the most advanced technology available in hemodynamic monitoring. The QMAPP amplifier has the small size of a ream of A4 paper, features all available vital monitoring parameters and has up to 32 bipolar intra-cardiac channels for electrophysiology procedures. QMAPP is perfectly suitable for today’s hybrid rooms, but also for combined and dedicated (cardiac) catheterization labs. QMAPP is fanless which minimizes the risk of cross contamination. The hardware design of QMAPP ensures a high level of usability, is connected via one single cable to the floor base of the X-Ray table and with a clamp mounted to the DIN-Rail. The acquired vitals and reporting entries can easily be exchanged with any EMR system using standard protocols like DICOM and HL7.
Invented, developed & produced in the Netherlands
“We are pleased to announce the FDA approval and look forward to the introduction of QMAPP in the United States, beginning with commercialization efforts in partnership with our distributors,’ said Linda Elberse, CEO.”