Israeli hematology company, PixCell Medical, received FDA 510(k) clearance for its direct capillary sampling method, utilizing their HemoScreen 5-part differential CBC analyzer. The novel technique is set to redefine simplicity in blood sampling by sidestepping intricate pre-analytical processes.
While the HemoScreen had already been greenlit by the FDA for POC applications with venous and capillary blood back in 2018, it's remained unparalleled as the sole 5-part differential CBC analyzer for point-of-care (POC) application. The latest clearance allows for a direct finger-prick method, bypassing the need for an intermediary tube. By comparison to alternative blood count instruments, HemoScreen's direct sampling exhibits unmatched user-friendliness. Not only does this bypass the need for professional expertise like a phlebotomist or physician, but it also promotes a swifter, more comfortable experience with a significantly diminished risk of pre-analytical errors.
The FDA recognition positions the startup as a market leading POC hematology device, complete with its unique one-time-use reagent cartridge, seamless sample prep, and straightforward blood collection system.
"This latest clearance is a major milestone and a profound vote of confidence, allowing HemoScreen users to utilize an exceptionally simple sampling procedure" commented 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."
PixCell Medical develops a one-of-a-kind 5-part differential Complete Blood Count (CBC) analyzer—HemoScreen™. It's armed with accolades and certifications from the FDA, CE, and TGA for POC utilization. A single drop of blood from a finger-prick unravels 20 standard blood count metrics in a mere five minutes on this compact, user-friendly platform. The company's technology portfolio is hinged on a patented cartridge loaded with essential reagents, along with the company's Viscoelastic Focusing technology and AI-based computer vision algorithms.
The company was acquired in 2021 by Soulbrain Holdings for an estimated $40 million.
