DYSIS has been formally evaluated by a number of regulatory bodies in different countries. Below are the summary details with links to further details where appropriate.
In 2011 the Food and Drugs Administration in the US granted DYSIS clearance to market. FDA determined that DYSIS with Pseudo-Color imaging (PCI, or DYSISmap) is a digital colposcope designed to image the cervix and lower genital tract under illumination and magnification.
Colposcopy is indicated for women with an abnormal Pap smear in order to affirm or detect abnormal appearances consistent with neoplasia, often with directed biopsy. The PCI feature is an adjunctive tool for displaying areas of aceto-whitening.
It is a tool that should not be used as a substitute for a thorough colposcopic evaluation.
DYSIS is CE marked and complies with the European Medical Device Directive.
DYSIS Medical Ltd. has ISO13485 certification for the quality management system used to design, manufacture and commercialize the DYSIS Colposcope.
DYSIS complies with the UK Conformity Assessment for medical devices.
In 2010 the UK Regulator, NICE (National Institute of Health and Care Excellence) launched an investigation into the clinical eﬃcacy and cost eﬃciency of various new technologies in the cervical screening category. The review involved an independent analysis of the published clinical trials followed by a detailed review of the health economics. In 2012, NICE first issued guidance that stated “DYSIS should be considered” as it was technology deemed to be both clinically effective and cost saving. Then, in 2018, NICE upgraded its guidance to “DYSIS is recommended.” DYSIS is currently the only adjunctive colposcopy technology recommended for routine adoption in the NHS cervical screening pathway.
The full report can be found by clicking below.
From April 2015, the DYSIS Colposcope has been recognised as an approved advanced technology by the NHS Cervical Screening Programme (NHSCSP) in the latest UK National Colposcopy Guidelines (Document 20).
The new release of the Document 20 guidelines advises on the latest advancements in cervical screening, and recognises the DYSIS Colposcope for its financial and clinical advantages. The guidelines particularly detail those benefits afforded by the technology relevant to other changes such as the introduction of HPV testing.
The guidelines can be accessed below:
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