CE mark for Trajan’s hemaPEN® blood microsampling device, now available for diagnostic use across EU and UK

7 May 2020

Trajan Scientific and Medical (Trajan) has declared hemaPEN® compliance with EU IVD Directive 98/79/EC, and its release for in vitro diagnostic use in the EU and UK. This follows the hemaPEN’s recent addition to the TGA’s ARTG (Australian Register of Therapeutic Goods) in February as a Class 1 IVD device.

This enables hemaPEN to be used to collect blood microsamples for clinical trials, diagnostics and applications to monitor health.

hemaPEN provides a convenient sampling procedure for collection and storage of four dried blood spot (DBS) samples. Unlike conventional DBS sampling tools, hemaPEN enables collection of an accurate and precise fixed micro-volume and is designed to maintain sample integrity for quantitative analysis. An easy to-use sophisticated microsampling tool in the hands of non-analysts.

In today’s environment, where whole communities are practising self-isolation due to COVID-19, remote microsampling facilitates ongoing blood monitoring of chronic disease, and enables continuity-of-care for vulnerable members of society.

Trajan’s CEO, Mr Stephen Tomisich said, “This is the tipping point for remote microsampling technology; alongside e-health consultations and e-prescription we are moving to a more remote healthcare system.”

Dr Anne Collins, Trajan’s Business Unit General Manager, Microsampling, said, “hemaPEN’s adoption in ongoing medical treatment and monitoring would remove the need for travel, reduce pressure on healthcare workers, and eliminate expensive cold chain logistics.”

Read the complete media release.


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