Thursday, August 24, 2023
PixCell Medical has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its HemoScreen 5-part differential CBC analyser.
The direct capillary sampling capability is a standout feature of the HemoScreen analyser, distinguishing it from other devices used for blood cell count. This approach simplifies the collection of capillary blood directly from a person's fingertip.
This method does not necessitate the presence of a phlebotomist or physician, making it more accessible and convenient. Additionally, the direct sampling technique is quicker, less painful, and minimises the chances of pre-analytical errors.
The HemoScreen analyser was initially cleared by the FDA for point-of-care use with both venous and capillary blood. However, with the recent clearance for direct capillary sampling, the HemoScreen device has taken a revolutionary step forward in point-of-care haematology.
Its operation has become even more straightforward, addressing common challenges associated with pre-analytical procedures that are often encountered with other CBC analysers.
The FDA's clearance for direct capillary sampling has unlocked the HemoScreen 5-part differential CBC analyser's full potential. The device's proprietary single-use reagent cartridge, automatic sample preparation, and simplified blood collection procedure, combined with its newfound capability, solidify its position as a game-changing point-of-care haematology analyser.
