Salute e Benessere
PixCell Medical's HemoScreen CBC Analyzer Achieves IVDR Certification--A Game-Changer for Point-of-Care Diagnostics
Dr. Avishay Bransky , CEO of PixCell Medical, remarked: "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."
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. The certification confirms HemoScreen's compliance with the highest industry benchmarks for safety and efficacy.
PixCell Medical, an innovator of rapid hematology testing solutions at the point-of-care, has developed the only 5-part differential Complete Blood Count (CBC) analyzer that is FDA-cleared for point-of-care use – the HemoScreen™.
HemoScreen enables healthcare providers to perform rapid, high-quality CBC testing with just a single drop of blood and minimal training. Its patented disposable cartridges, preloaded with reagents, combined with AI-powered machine vision and Viscoelastic Focusing technology, make it uniquely suited for decentralized medical environments such as clinics, emergency rooms, and remote locations.
For more information: www.pixcell-medical.com
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PixCell Medical
Jake Jones
jake.jones@pixcell-medical.com
View original content:https://www.prnewswire.co.uk/news-releases/pixcell-medicals-hemoscreen-cbc-analyzer-achieves-ivdr-certificationa-game-changer-for-point-of-care-diagnostics-302317346.html