Trinity Biotech develops, manufactures, and markets clinical-laboratory and point-of-care diagnostic systems, with a long-established specialty in infectious-disease assays and haemoglobin analysis. The Ireland-based company is now extending that diagnostic expertise into biosensors, including a continuous glucose-monitoring platform in development, while serving customers through partners in more than 100 countries. Its U.S. and Irish facilities are FDA- and ISO-registered, including ISO 13485 and MDSAP certifications.
FDA Registered
Registration
ISO 13485
MDSAP
Compliance program
CAN/CSA ISO 13485:03
FDA 510(k) Cleared
Registration
World Health Organization Prequalified
Registration
CE Marked
FDA
Quality certification
WHOPREQUALIFICATION
Quality certification
AbbottAbbott develops and manufactures healthcare technologies and products spanning diagnostics, medical devices, nutrition and medicines, with solutions that range from FreeStyle Libre glucose monitoring to cardiovascular therapies. The company operates in more than 160 countries and has built substantial manufacturing and research footprints in markets including Ireland, Singapore, China and India. Its work connects laboratory testing, chronic-disease management and everyday nutrition across different stages of life.COLUMBUS, OH
Tetracore, IncFor more than 20 years, Rockville-based Tetracore, Inc. has developed diagnostic reagents, assays, and instruments that detect infectious diseases and biothreat agents. Its work spans human and animal health, domestic preparedness, and forensic biology, including the T-COR 8 portable PCR thermocycler and the BioThreat Alert testing platform. Tetracore’s quality system is certified to ISO 13485 and ISO 9001, with laboratories accredited to ISO/IEC 17025.ROCKVILLE, MD
Advanced Biomimetic Sensors, IncFounded in 2006 by CEO Ellen T. Chen, Ph.D., Bethesda-based Advanced Biomimetic Sensors is a woman-owned small business developing medical diagnostic and monitoring devices built around nanobiomimetic, reagent-free sensing. Its work includes handheld systems for triple-negative breast cancer monitoring and blood-glucose testing, alongside the patented QSensing® platform for detecting proteins in human serum. The company’s technology has received National Innovation Awards in 2017 and 2018 and a National Defense Innovation Award in 2022.BETHESDA, MD
iWel Health InciWel Health is an Exton, Pennsylvania biosensing company whose leadership brings deep experience from Pfizer, Bayer and the medical-device field. It develops continuous glucose monitoring technology for metabolic-health coaching, with particular attention to wellness users and people managing prediabetes or Type 2 diabetes.EXTON, PA