YOKNEAM, Israel, Nov. 7, 2018 -- PixCell Medical announced today that The HemoScreen™ Hematology Analyzer received FDA 510(k) clearance, enabling commercialization in the USA.
The HemoScreen™ is a miniature portable hematology analyzer that uses disposable cartridges; each cartridge includes all necessary reagents and is designed to accept a drop of blood taken from the finger. The operation of the device is exceptionally simple and requires minimal training or expertise. Once the cartridge is inserted into the reader, the blood sample is automatically processed and analyzed within the cartridge and thus the concept is termed by the company "Lab On a Cartridge".
"We are very excited to have reached this important milestone," says Dr. Avishay Bransky PixCell's CEO, "we have solved a decades-long problem of making a miniature POC CBC tester which is widely recognized as an unmet need."
"The HemoScreen delivers lab accurate results and would be especially useful at physicians' offices, ER, ICU, Oncology clinics and remote locations," says Dr. Bransky.
In contrast to existing solutions, the HemoScreen requires no maintenance or calibration which is extremely important in such settings.
The HemoScreen™ should empower physicians to make validated, data-driven decisions: referring patients to the ER, prescribing antibiotics and other medication, ordering additional specific tests while reducing redundant tests and by that greatly improve patient care and workflow efficiency.
The CBC is the most commonly performed lab test with nearly 2 billion tests per year in the USA and Europe. The CBC provides an important tool for evaluating patients' overall health and managing a wide range of disorders including infection, anemia and leukemia.
Performance of the HemoScreen™ has been validated in numerous clinical studies in the USA and Europe, in different settings such as oncology, ICU and primary care.
The HemoScreen™ employs patented technology based on microfluidics, machine vision and artificial intelligence (AI). Utilizing a new concept: Imaging Flow Cytometry where cells are flow focused into a single layer plane within a microfluidic chamber and their images are analyzed on the fly. This approach provides high repeatability and accuracy arising from flow and high resolution and sensitivity attained by imaging.
Future assays based on the same platform technology are designed to detect the leading life-threatening diseases already at the POC i.e. cancer, infection, and heart failure.