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.
MaaT Pharma reveals positive 18-month data for MaaT013 in GI-aGvHD
Innate Pharma advances Sanofi-developed NK cell engager to Phase 2 for blood cancer patients
Precision Epigenomics partners with TruDiagnostic
Illumina's GRAIL divestment plan receives EC approval
Soligenix receives orphan drug designation from FDA for active ingredient in SuVax
Candel Therapeutics granted FDA Orphan Drug Designation for CAN-2409 in pancreatic cancer treatment
Lipogems completes patient enrolment in ARISE I US FDA IDE study
Amylyx Pharmaceuticals' AMX0035 shows promising impact on Wolfram syndrome symptoms
Ondine Biomedical's Steriwave approved for use by HCA UK
Roche attains CE Mark for first companion diagnostic for HER2-low metastatic breast cancer
Cadrenal Therapeutics' tecarfarin receives US FDA Orphan Drug Designation
BioCity Biopharma's BC2027 Phase one study IND application receives US FDA approval
Seres Therapeutics completes patient enrollment for SER-155 Phase 1B trial
Syros receives Fast Track Designation from FDA for tamibarotene in AML