PixCell Medical, a leading innovator in point-of-care diagnostics, proudly announces that its groundbreaking HemoScreen CBC analyzer has achieved certification under the In Vitro Diagnostic Medical Devices Regulation (IVDR) (EU) 2017/746. As the only FDA-cleared, point-of-care 5-part differential Complete Blood Count (CBC) analyzer, HemoScreen is now also the first device of its kind to meet the stringent IVDR requirements. This dual milestone cements PixCell Medical’s position as a pioneer in advancing patient care through rapid, accurate, and portable diagnostic solutions.
By securing IVDR certification years ahead of the regulatory deadline, HemoScreen reaffirms PixCell Medical’s proactive commitment to quality, safety, and innovation. The rigorous certification process validated the analyzer’s clinical performance, safety, and reliability across diverse healthcare settings, underscoring its role as a lab-accurate diagnostic tool at the point of care.
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.
