Clinical diagnostics company Beckman Coulter disclosed on Thursday the receipt of the US Food and Drug Administration's (FDA) 510(k) clearance to market the DxH 520 hematology analyzer in the laboratories, clinics and physician offices in the US.
The company added that the DxH 520 features unique technology that improves sample flagging by 40%, ensuring better first-pass yield and accurate differentials with as little as 17 microliters of blood. Its accurate, rapid and reliable results with a small drop of blood makes its ideal for neonate, pediatric and critical-care patients.
According to the company, the DxH 520 includes five part differential testing in a compact and cost-effective package, small sample volume requirement well suited to patients with difficult blood draws, only three screen touches to access any menu, cost-effective, easy waste disposal as well as closed tube analyzer for enhanced safety.
In conjunction, the company's DxH 520's closed tube aspiration capability reduces manual steps and ensures safety for laboratorians by eliminating sample exposure and risk of contact with blood-borne pathogens. The analyzer features a robust patient data and quality control (QC) management system that allows for easy retrieval from a vast storage database of up to 30,000 patient samples--or over 16 months of clinical data in heavy-use scenarios.
Concurrently, the DxH 520's friendly reagents reagents are water-based and cyanide-, azide- and formaldehyde-free. This approach eliminates the disposal costs associated with competitive systems that employ multiple reagents and/or harsh solvents, concluded the company.
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
Ligand Pharmaceuticals announces presentation of Captisol-enabled Topiramate Injection data