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.
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.
PixCell Medical CEO Dr Avishay Bransky commented: "Achieving IVDR certification for HemoScreen is more than a regulatory milestone – it's a validation of our mission to transform diagnostics at the point of care.
“By meeting the strictest regulatory standards in both the EU and the US, we're ensuring that healthcare providers worldwide have access to reliable, innovative tools that enhance patient care."
As of May 2024, PixCell Medical had eight in vitro diagnostic products in various stages of development, as per GlobalData analysis. The company’s main research and development focus is infectious diseases, followed by cancer, cardiovascular, and haematologic diseases.
According to GlobalData’s Market Size & Growth database, the CBC segment of the global haematology tests market was valued at around $1.095bn last year and is forecast to reach a valuation of around $1.149bn by 2033.
In other recent IVDR news, Qiagen received the CE mark for its QIAstat-Dx syndromic testing systems and associated assays, and AliveDx for its MosaiQ AiPlex CD microarray immunoassay for the diagnosis of celiac disease.
