FDA Approval for HemoPoint® H2 Data Management System
Regarding the special directives for medical devices in the US market, EKF cooperates closely with Stanbio Laboratory in Boerne, Texas as a strong player in the diagnostic market. Distributed under its own brand and private label, the HemoPoint® H2 is brought in many institutions from Los Angeles to New York. An essential condition for this market success was the approval by the US Food and Drug association (FDA), well known for their very restrictive regulations.
Covering growing demands in patient and data management, EKF has also developed an expanded "Manager" version of its analyzer. This device is featured by Barcode reader, wireless Bluetooth-interface and PC software for continual monitoring of patient and user data, including applied consumables and quality controls. Additionally, the internal memory is increased to 4.000 measurement results including the named parameters. A very complex system, but simply to use thanks its smart user interface with graphical touch screen.
Proven thoroughly by the FDA again, Stanbio received now the official approval for the HemoPoint® H2 Data Management System and starts the market introduction in the US. William R. Pippin, president of Stanbio: "German engineering has an international top rank, and we are enjoyed to contribute with EKF to the success of German-American cooperation. Our customers appreciate the high quality of the HemoPoint® H2-analyzer, and the expanded Data Management System gives them an impressing option in featuring and performance."
The portfolio of the EKF-diagnostic GmbH also comprises modern devices for glucose and lactate analysis, added by sales and development agreements for further diagnostic applications. Besides company's presence at international congresses and trade fairs, EKF shows its latest innovations at the biggest international exhibition of the medical industry, the MEDICA in Duesseldorf.
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