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.
Bioeq and Zydus partner for US commercialisation of Lucentis biosimilar NUFYMCO
Sanofi receives FDA complete response letter for tolebrutinib in progressive MS
Aqualung Therapeutics' Phase 2a lung fibrosis study approved by US FDA
AstraZeneca secures US Breakthrough status for Enhertu in early breast cancer
Shield Therapeutics wins FDA approval to expand ACCRUFeR use to adolescents
ECO Animal Health Group secures EU approval for ECOVAXXIN MS
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