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Trajan's Microsampling Devices Comply with IVDR Requirements in Europe and the UK

Friday, June 02, 2023

Trajan Scientific and Medical, a prominent provider of analytical and life sciences solutions, has recently announced the regulatory approval of its Neoteryx Mitra® and hemaPEN® remote blood microsampling devices for clinical use in Europe and the UK.

The company has successfully met the stringent safety and performance requirements set forth by the In Vitro Diagnostic Medical Devices Regulation (IVDR) in Europe and the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK. This achievement, marked by the CE compliance certification, expands the applications of Trajan's Neoteryx® microsampling products, facilitating decentralized, patient-centered, and minimally invasive blood collection in clinical and research settings.

The Mitra® device, utilizing volumetric absorptive microsampling technology (VAMS®), offers a fingerstick blood collection solution for the transportation of dried samples to the laboratory. Similarly, the hemaPEN® device utilizes advanced volumetric microsampling combined with capillary and dried blood spot (DBS) technology, enabling the simultaneous collection of four DBS blood samples of equal volume through a single finger prick.

These innovative devices enable remote blood sampling through a simple and nearly painless procedure. Dried samples can be conveniently sent via regular mail, ensuring precise volume and high sample quality compared to traditional DBS or other remote blood collection methods. Moreover, these samples seamlessly integrate into laboratory analysis workflows, as evidenced by studies conducted by pharmaceutical companies, healthcare organizations, and academic institutions worldwide.

Stephen Tomisich, CEO and Founder of Trajan, expressed his enthusiasm for the updated regulatory approvals, emphasizing their significance in advancing personalized, preventive, and data-driven healthcare. He believes that Trajan's expanding range of microsampling technologies empowers individuals to easily obtain analytically valuable samples outside of traditional clinical environments—anytime, anywhere. Tomisich sees this capability as a critical factor in shaping the healthcare systems of the future.

 

Source: prnewswire.com

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