Trajan Scientific and Medical (Trajan) has received approval for two new Neoteryx remote blood microsampling devices for clinical application in Europe and the UK.
The two approved devices, namely Mitra and hemaPEN, met all the necessary safety and performance requirements of the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK and the In Vitro Diagnostic Medical Devices Regulation (IVDR) in Europe.
After receiving the CE mark, the company plans to extend the capabilities of its microsampling products.
The improved products will be able to support person-centred, decentralised, minimally invasive blood collection in both research and clinical settings.
Trajan founder and CEO Stephen Tomisich said: “The updated regulatory approval of Trajan’s blood microsampling devices in the UK and European Union is another step forward towards our vision of personalised, preventative data-based healthcare.
“Our growing range of microsampling technologies allows almost anyone to take an analytically viable sample outside the clinical setting, anytime, anywhere. In our view, that is essential to enable the healthcare systems of the future.”
The Mitra device is a finger-stick blood collection solution used to deliver dried samples to the lab. It leverages VAMS technology for volumetric absorptive microsampling.
The hemaPEN device, which uses capillary and next-generation dried blood spot (DBS) technology for volumetric microsampling, deploys a single finger stick to simultaneously collect four volumetrically identical DBS blood samples.
Using an easy, virtually painless procedure, both devices enable the remote collection of blood samples. The devices facilitate the shipping of dried samples through standard mail.