FDA grants 510(k) clearance to Fysicon’s QMAPP haemodynamic monitoring system


Fysicon has announced that it has received 510(k) FDA clearance for its QMAPP haemodynamic monitoring system. A press release reports that QMAPP offers cardiologists the most advanced technology available in haemodynamic monitoring. It adds that 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.

According to the press release, QMAPP is perfectly suitable for today’s hybrid rooms, but also for combined and dedicated (cardiac) catheterisation labs. QMAPP is fanless, the goal of which is to minimise 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.

Linda Elberse, chief executive officer of Fysicon, says: “We are pleased to announce the FDA approval and look forward to the introduction of QMAPP in the USA, beginning with commercialisation efforts in partnership with our distributor.”


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