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Disclaimer

The Etrending® product is currently in development. The intended use of the software is for data scoring, management & trending. The service being provided is to initiate feedback which will be used to determine the direction of the product and its content. The use of the product by a user during this development assumes that they have read, understood and agreed with the following conditions of use.

  • The software is not to be distributed or displayed to third parties without the express permission of PHD Medical.
  • The software is not to be used for the production or analysis of clinical data (For evaluation purpose only).
  • No diagnosis should be made fully or in part from the data produced by this application.
  • The continual service of the application cannot be guaranteed.
  • The availability of information entered into this application cannot be guaranteed.
  • The functionality of the application will change at regular intervals as newer versions are introduced.

Etrending® has been developed in accordance with guideline set out in ISO 9001:2008 and ISO 13485:2003. PHD Medical is in the process of adding the product to the scope of its approved Medical Device Certification portfolio through SGS International.

Validation of the Etrending® scoring tools has been initiated and is being completed using methods approved by the FDA. The Etrending® scoring software has been validated against the leading oximetry scoring software and scoring undertaken manually by leading professionals in the field of sleep medicine using real clinical data. Preliminary results indicate that Etrending® is more accurate and more reliable in all fields when compared to the leading competitor and equivalent when compared to manual scoring of sleep medicine derived clinical data. Etrending® product design, manufacture & validation processes will be submitted as part of the ongoing application for FDA 510(K) approval.