FinCCHTA

Kansallinen HTA-koordinaatioyksikkö FinCCHTA
PL 10, 90029 OYS

fincchta@ppshp.fi

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The Orla INR Remote Monitoring

Valid to: 01.2025

Information about the product

The Orla INR Remote Monitoring supports warfarin treatment with the help of self-measurement or self-care. The product consists of a mobile application intended for patients and a web-based service intended for professionals. The patient measures the INR value by using the Roche Diagnostics CoaguChek® INRange measurement device, which is connected to the Orla INR Remote Monitoring mobile application with a Bluetooth connection. The patient mobile application includes an electronic warfarin card and it seeks to remind the patient of the measurements to be made as well as to notify of any adjustments in the warfarin dosage made by the health care professionals. The patient’s measurement data are available for the health care professionals with an access through the cloud service.

According to the company’s declaration, this product is not a medical device, so it should not be used in any intended uses of the medical devices.

Additional information

Language
  • Finnish
  • Swedish
  • English
Certificates
  • CE-marked (INR-mittalaite)
Desktop

Conclusion 19.1.2022

The product meets the assessment criteria

The Orla INR Remote Monitoring is suitable for self-measurement or self-care of patients provided with warfarin treatment. Special attention must be paid to patient selection and patient counselling.

The assessment is based on the information provided by the company.

Assessment fields

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