PixCell Medical’s HemoScreen Receives FDA Approval

PixCell FDA. Credit - PixCell

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.

Mentioned in the article

Continue Reading

StartupHub.ai, the hub of the AI startup ecosystem.

Add or Claim Your Profile

Submit the form below to add or claim an existing profile. Within 24 hours, we'll review your request and connect you to your existing profile for full editing.

Pro Lite Subscription Required

Unlock all search results

With a Pro Lite subscription, you can enjoy unlimited profile viewing. Power your innovation efforts, uninterrupted.


cancel anytime

Pro Lite includes: