Microsampling Devices

Micro Sampling Devices Trajan's Micro Sampling Devices Meet IVDR Compliance in Europe and the United Kingdom Trajan Scientific and Medical, a leading provider of analytical and life sciences products and solutions, has announced regulatory approval for Neoteryx remote blood micro sampling devices Mitra® and hemaPEN® for clinical use in Europe and the United Kingdom. Trajan has successfully met the 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. With this CE Mark regulatory compliance approval, Trajan is expanding the capabilities of Neoteryx® micro sampling products to enable decentralized, person-centric, minimally invasive blood collection in both clinical and research settings. The Mitra device, based on volumetric absorptive micro sampling with VAMS® technology, is a fingerstick blood collection solution for the transmission of dried samples to the laboratory. The hemaPEN® device, based on capillary and next-generation volumetric micro sampling DBS technology, uses a single finger stick to simultaneously collect 4 DBS blood samples of equal volume. The Mitra® and hemaPEN® devices can be used to collect remote blood samples through an easy and nearly painless procedure. The devices allow for the transmission of dried samples by standard post and provide accurate volumes and high sample quality compared to conventional DBS or other remote blood sampling technologies. The samples integrate seamlessly into laboratory analytical workflows, as demonstrated in studies conducted by pharmaceutical companies, healthcare institutions and academic organizations around the world. Trajan CEO and founder Stephen Tomisich stated, "The updated regulatory approval of Trajan's blood micro sampling devices in the United Kingdom and the European Union is another step towards our vision of personalized, preventive, data-driven healthcare services," and added "Our expanding range of micro sampling technologies enables almost anyone to obtain an analytically suitable sample outside the clinical setting, at any time, anywhere. In our view, this is critical to enabling the healthcare systems of the future." Source