POC diagnostic device company PixCell Medical disclosed on Wednesday that its HemoScreen Hematology Analyzer will be commercialised in the US, following FDA 510(k).
PixCell Medical said the HemoScreen is a miniature portable hematology analyzer. It has a disposable cartridge that includes all necessary reagents and is designed to accept a drop of blood taken from the finger. When the cartridge is inserted into the reader, the blood sample is automatically processed and analyzed within the cartridge, a concept termed by the company as "Lab On a Cartridge".
The company added that HemoScreen requires no maintenance or calibration and is expected to enable physicians to make validated, data-driven decisions: referring patients to the ER, prescribing antibiotics and other medication and ordering additional specific tests, while reducing redundant tests.
According to PixCell Medical, the performance of the HemoScreen has been validated in several clinical studies in the USA and Europe, in various settings such as oncology, ICU and primary care. The hematology analyzer uses patented technology based on microfluidics, machine vision and artificial intelligence (AI). It utilises a new concept: Imaging Flow Cytometry where cells are flow focused into a single layer plane within a microfluidic chamber.
Hansa Biopharma submits imlifidase Biologics License Application to FDA
T-MAXIMUM Pharmaceutical receives IND approval to start Phase II trial of MT027 for rGBM
Alvotech and Teva secure US launch date for Eylea biosimilar AVT06
Egetis initiates rolling US NDA for Emcitate in MCT8 deficiency
Abbott's Amplatzer Piccolo Delivery System receives US FDA clearance and CE Mark
Amphix Bio announces initial closing of USD12.5m seed financing round
BiBBInstruments reports additional US orders during targeted EndoDrill GI launch
Sanofi's efdoralprin alfa receives EU orphan designation for AATD-related emphysema
Black Buffalo partners with Sanova to support regulatory strategy and scientific innovation
Nicox completes key data package for NCX 470 NDA submissions
Immusoft's ISP-002 granted US FDA Orphan Drug Designation in MPS II
Orphan Therapeutics Accelerator signs MoU with Fondazione Telethon
Bioretec wins FDA breakthrough status for biodegradable orthopaedic DrillPin
Amferia raises EUR3.5m to advance antimicrobial wound-care platform
Sobi s Aspaveli marketing authorisation receives positive European regulatory opinion