PixCell Medical is pleased to announce that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for direct capillary sampling with the HemoScreen 5-part differential CBC analyzer, substantially simplifying blood sampling and minimizing the pre-analytical process.
| YOKNEAM ILLIT, Israel, Aug. 23, 2023 /PRNewswire/ -- PixCell Medical, an innovator of rapid hematology testing solutions at the point of care (POC), is pleased to announce that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for direct capillary sampling with the HemoScreen 5-part differential CBC analyzer, substantially simplifying blood sampling and minimizing the pre-analytical process. 
HemoScreen has been FDA-cleared for point-of-care use with venous and capillary blood since 2018, and to date has been the only 5-part differential CBC analyzer cleared for POC use. The recent clearance enables collection of a sample directly from the finger without an intermediate tube. Direct sampling is a significant advantage over other blood count devices, as it enables unparalleled ease of capillary blood collection that does not require a phlebotomist or physician, requires much less expertise, is quicker, painless, and is much less prone to pre-analytical errors. This recent FDA clearance has finally brought HemoScreen to its full potential as a true POC hematology analyzer with its proprietary single-use reagent cartridge, automatic sample preparation, and exceptionally simple blood collection procedure. “This latest clearance is a major milestone and a profound vote of confidence, allowing HemoScreen users to utilize an exceptionally simple sampling procedure” states Dr. Avishay Bransky, PixCell Medical co-founder and CEO. “With the clearance to use direct capillary sampling, HemoScreen has become a true game changer in POC hematology, making it even easier to operate, negating pre-analytical challenges common with other CBC analyzers in the market, and increasing diagnostic throughput.” About PixCell Medical 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, CE-marked, and TGA-approved for point-of-care use –the HemoScreen™. The portable, easy-to-use platform offers clinically proven lab-accurate readings of 20 standard blood count parameters within five minutes, with just one finger-prick of blood. This facilitates fast diagnostic results and data-driven disease management decisions. Leveraging a patented, disposable cartridge preloaded with all necessary reagents, the company’s unique Viscoelastic Focusing technology, and AI-powered machine vision, PixCell enables improved medical outcomes and patient quality of life and reduces costs for healthcare providers. For more information: www.pixcell-medical.com Media Contact: Logo: https://mma.prnewswire.com/media/1501459/PixCell_Medical_Logo.jpg
SOURCE PixCell Medical |
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