Trajan's Microsampling Devices Meet IVDR Compliance in Europe, UK
MELBOURNE, Australia, June 2, 2023 /PRNewswire/ -- Trajan Scientific and Medical, a leading provider of analytical and life sciences products and solutions, today announced the regulatory approval of its Neoteryx remote blood microsampling devices, Mitra® and hemaPEN® for clinical use in Europe and the United Kingdom.
- Trajan has successfully fulfilled the required product safety and performance requirements under the In Vitro Diagnostic Medical Devices Regulation (IVDR) in Europe and the Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom.
- Having earned this CE Mark regulatory compliance, Trajan expands the capabilities of its Neoteryx® microsampling products to provide decentralised, person-centered, minimally invasive blood collection in both clinical and research settings.
- Mitra® and hemaPEN® devices can be used remotely to collect blood samples through an easy, virtually painless process.
- "The updated regulatory approval of Trajan's blood microsampling devices in the UK and European Union is another step forward towards our vision of personalized, preventative data-based healthcare," said Stephen Tomisich, CEO and founder of Trajan.