ALK (ALKB/ OMX: ALK B / AKABY / AKBLF), a Denmark based provider of allergy prevention, diagnosis and treatment, announced on Monday that it has received U.S. FDA approval for its new line of AccuTest Allergy Skin Testing Devices, designed to enhance the accuracy and reliability of allergy testing and diagnosis.
This product line includes single-prick and multi-head devices, AccuTest-1, AccuTest-8 and AccuTest-10, as well as allergen well trays, aimed at improving diagnostic precision and patient comfort.
The multi-head applicators, available in 8-head and 10-head configurations, offer ergonomic designs with ribbed grips and larger top surface areas for more uniform pressure application, contributing to consistent results. The single-prick device, AccuTest-1, and the multi-head models feature smaller tines to improve accuracy and minimize discomfort.
AccuTest allergen well trays, compatible with the devices, feature a non-slip base and air-tight locking mechanism to prevent contamination, ensuring stability and accuracy during testing.
A recent study highlighted the AccuTest line's precision and its potential to reduce device variability, which could improve the reliability of allergy test results.
DATROWAY receives US priority review for first-line metastatic triple negative breast cancer
Lupin launches Dasatinib tablets in US market
Natera submits Signatera CDx PMA to FDA for bladder cancer use
Pharming receives FDA complete response letter for paediatric Joenja application
Trace Biosciences' IND application for nerve-specific imaging agent approved by FDA
Frontage expands early phase clinical research capabilities across US and China
MicuRx Pharmaceuticals' IND application for MRX-5 cleared by FDA
FDA approves Tenpoint Therapeutics' YUVEZZI as first dual-agent eye drop for presbyopia
Summit Therapeutics' BLA for ivonescimab in EGFR-mutated NSCLC accepted by FDA
WuXi Biologics collaborates with Sinorda Biomedicine for antibody development
Biogen's litifilimab receives FDA Breakthrough Therapy Designation for CLE
Glaukos receives FDA approval for repeat administration of iDose TR
Guerbet's contrast agent Elucirem approved by European Commission in children from birth
Spine Innovation's LOGIC Titanium Implant System receives US FDA 510(k) market approval