PixCell Medical’s HemoScreen CBC Analyzer Receives IVDR Certification, Advancing Point-of-Care Diagnostics

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78a13171167934c2883cf1dfa16d3be8 PixCell Medical's HemoScreen CBC Analyzer Achieves IVDR Certification--A Game-Changer for Point-of-Care Diagnostics

YOKNEAM ILIT, Israel, November 27, 2024 — PixCell Medical, a leader in point-of-care diagnostics, announces its HemoScreen CBC analyzer has received In Vitro Diagnostic Medical Devices Regulation (IVDR) (EU) 2017/746 certification. As the only FDA-cleared, point-of-care 5-part differential Complete Blood Count (CBC) analyzer, HemoScreen is the first of its kind to meet IVDR standards. This achievement solidifies PixCell Medical’s role in providing rapid, precise, and portable diagnostic solutions.

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HemoScreen’s early IVDR certification demonstrates PixCell Medical’s dedication to quality, safety, and innovation. The rigorous process confirmed the analyzer’s clinical performance, safety, and reliability in various healthcare settings, highlighting its lab-quality accuracy at the point of care.

Dr. Avishay Bransky, PixCell Medical’s CEO, stated: “HemoScreen’s IVDR certification validates our commitment to transforming point-of-care diagnostics. Meeting stringent EU and US regulatory standards ensures healthcare providers globally have access to reliable, innovative tools improving patient care.”

Dekra, the EU Notified Body, conducted PixCell Medical’s IVDR certification, evaluating clinical evidence, performance data, and post-market surveillance. The certification confirms HemoScreen adheres to the highest safety and efficacy standards.

About PixCell Medical
PixCell Medical, an innovator in rapid point-of-care hematology testing, created the only FDA-cleared 5-part differential Complete Blood Count (CBC) analyzer for point-of-care use – the HemoScreen™.

HemoScreen allows healthcare providers to conduct rapid, high-quality CBC testing using a single blood drop and minimal training. Its patented disposable cartridges, pre-filled with reagents, along with AI-powered machine vision and Viscoelastic Focusing technology, make it ideal for decentralized settings like clinics, emergency rooms, and remote areas.

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Media Contact:
PixCell Medical
Jake Jones

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