miDiagnostics starting early preparation for regulatory clearance

Leuven, Belgium   I   October 2019


miDiagnostics has agreed a partnership with Notified Body, BSI (the Netherlands) to assess and certify the miDiagnostics Quality Systems to ISO 13485 (2016) in preparation for the CE marking and 510(k) clearance of the miDiagnostics range of diagnostic devices.

miDiagnostics is developing a new generation of disposable tests that require only drops of blood and allow detection of cells, proteins, nucleic acids, and/or small molecules.

Its core technology is a novel silicon-based nanofluidic processor that automatically processes the blood sample without the need of pumps or valves.

There is no need for complex and costly instrumentation enabling medical decisions to be taken at the point of need or remote areas with a high level of comfort to both patients and caregivers.

“We are very delighted to announce our readiness for this next key phase of our development. This partnership with BSI brings us one key step nearer to the market,”

Ben Chambers, VP Quality and Regulatory Affairs

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miDiagnostics is using silicon chip technology which will bring miniaturized, rapid, easy-to-use, lab-quality tests with built-in connectivity direct to the patient and clinician.
Combining a nanofluidic processor on a chip and a compact reader, miDiagnostics can measure virtually any biomarker from an easily accessed sample such as drops of fingerprick blood. The Company is developing an extensive portfolio of tests for screening, diagnosis and monitoring of a wide range of health conditions, including infectious diseases.
Spun out of the world-leading R&D and innovation hub in nanoelectronics and digital technologies, imec, and a research collaboration with Johns Hopkins University, the leading US research and medical centre, miDiagnostics’ goal is to enable fast, comprehensive and cost-effective health analysis, regardless of location.  Based in Leuven, Belgium, miDiagnostics is a privately held company created in 2015.
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