Israel-based PixCell Medical has received a CE mark for HemoScreen, a complete blood count analyser (CBC), under the EU’s In Vitro Diagnostic Medical Devices Regulation (IVDR).
HemoScreen is a point-of-care haematology analyser that features a single-use reagent cartridge, automatic sample preparation, and a straightforward blood collection procedure.
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The device secured 510(k) clearance from the US Food and Drug Administration last year.
Lab-grade analysis is possible from a single blood drop sample as it passes through the device’s ‘lab-on-a-cartridge’ due to PixCell’s AI-assisted viscoelastic focusing (VEF) technology.
According to PixCell, VEF causes cells to align into a single layer, thereby facilitating their optical analysis.
PixCell Medical’s IVDR certification process was conducted by DEKRA, its EU Notified Body, and involved thorough evaluations of clinical evidence, performance data, and post-market surveillance standards.
