Tipping points in remote healthcare: Trajan’s hemaPEN® blood microsampling device
Tipping point in remote healthcare:
Trajan’s hemaPEN blood microsampling device cleared by US FDA + Registrations for use in Europe, the UK and Australia.
Trajan’s hemaPEN® blood microsampling device is cleared by the U.S. Food and Drug Administration (US FDA) as Class I device for therapeutic and in vitro diagnostic (IVD) use. Following on recent registrations for IVD use in Europe, the UK and Australia, hemaPEN® enables more flexible blood sampling compared to traditional phlebotomy (blood draw) for scientific and clinical communities.
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.”
Trajan believes in science that benefits people – creating portable and affordable measurement solutions, enabling accurate results to inform preventative healthcare.
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FEB 2020: TGA Registration
hemaPEN® device has been included on the TGA’s Australian Register of Therapeutic Goods (ARTG) as first microsampling device for use in Australia. Class 1 IVD device.
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MAY 2020: COMPLIANCE EU IVD Directive 98/29/EC
hemaPEN® compliance with EU IVD Directive 98/79/EC, and its release for in vitro diagnostic use in the EU and UK.
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JULY 2020: LISTING US FDA
hemaPEN® blood microsampling device listed with the U.S. Food and Drug Administration (US FDA) as Class I for therapeutic and in vitro diagnostic (IVD) use.
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