NEW YORK – PixCell Medical on Wednesday said its point-of-care HemoScreen CBC analyzer has received certification under Europe's In Vitro Diagnostic Medical Device Regulation (IVDR).
The Israeli firm said the certification process was used to validate the performance, safety, and reliability of its five-part differential complete blood count analyzer. The instrument uses disposable reagent cartridges, artificial intelligence-based analysis, and viscoelastic focusing technology for rapid testing from a drop of blood in clinics, emergency rooms, and remote locations.
The firm secured US Food and Drug Administration clearance for its HemoScreen analyzer in 2018, and it received an additional clearance last year for direct capillary sampling from a patient's finger in addition to the previous clearance for use of the instrument with venous and capillary blood samples.
"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," PixCell CEO Avishay Bransky said in a statement.
The firm said that the IVDR certification process involved evaluation of clinical evidence, performance data, and post-market surveillance standards.