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Siemens Healthineers Mobile Computer for POC Testing Nabs FDA 510(k) Clearance

NEW YORK – Siemens Healthineers announced on Thursday it has received 510(k) clearance from the US Food and Drug Administration for the Epoc NXS Host mobile computer.

Epoc NXS Host has also received the CE Mark, Siemens said.

Siemens' Epoc Blood Analysis System with Epoc NXS Host comprises a handheld point-of-care blood testing system powered by Android that provides color-coded test results quickly and simplifies and streamlines the blood gas testing process and inventory management with a single, room-temperature stable test card. It has a critical care menu that includes blood gases, a basic metabolic panel, along with hematocrit and lactate.

Test results are delivered to the laboratory information system or hospital information system via a wireless connection for integration into hospital networks with the Siemens Healthineers Point of Care Ecosystem, the Erlangen, Germany-based company said.

"Effective point-of-care testing requires instruments that deliver quick results, are easy to use, and offer safeguards both for patient security and quality test results," Christoph Pedain, head of Point of Care Diagnostics, Siemens Healthineers, said in a statement. "The Epoc Blood Analysis System with the new NXS Host offers clinical workflow improvements so that frontline healthcare workers can get comprehensive critical care test results quickly and accelerate care for their patients."