the microsampling blog / remote technologies

In the US, use of the Mitra device is limited to research and non-diagnostic applications. In many countries outside the US, the Mitra device can be used as a sample collection device for clinical diagnostic applications, as referenced in some content.

how remote microsampling supports virtual clinical trials and cuts costs

by Neoteryx | 5 min read

how remote microsampling supports virtual clinical trials and cuts costs

According to a 2014 study, the cost of developing a new drug is $2.6 billion. This high expense doesn’t include the additional cost of post-approval development to determine dosage strengths …

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new terms for remote research, virtual trials and monitoring

by Neoteryx | 3 min read

new terms for remote research, virtual trials and monitoring

The COVID-19 pandemic and its shelter-in-place requirements greatly accelerated the adoption of digital healthcare technologies and remote research or healthcare options. Conventional research studies, including clinical trials, required participants to …

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The Mitra Device is a single-use, non-sterile device used as a specimen collector and for the storage and transport of blood or other biological fluids. It is designed to be used by laboratory and healthcare professionals, or end-users as a container to collect and transport blood or other biological fluids. It is not specific to any clinical test, and is not for use in diagnostic procedures. Use of the Mitra Microsampler in Laboratory Developed Tests (LDTs) requires further processing including the establishment of performance characteristics and successful validation by the laboratory in a manner consistent with CLIA and/or other regulatory requirements.
The Mitra Microsampling Device is a FDA listed Class 1 exempt device, CE-IVD self-certified in the UK and EU, a Class I IVD in Australia, and registered with Health Canada. Neoteryx operates a Quality Management System (QMS) that is based on FDA good manufacturing practices, 21 CFR 820 regulations, and ISO-13485.
Copyright © 2019 Neoteryx, LLC. All rights reserved.