FinCCHTA

Kansallinen HTA-koordinaatioyksikkö FinCCHTA
PL 10, 90029 OYS

fincchta@ppshp.fi

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Kaiku® Health Service for symptom management of cancer patients

Valid to: 09.2023

Information about the product

The Kaiku® Health service is a digital system that can be used to monitor the well-being of a patient with cancer. This service can be accessed via either a web browser or a mobile application. Through the service, the patient fills in symptom monitoring and a quality of life meter, and if necessary, the system sends information about the deterioration of well-being to the treating organization. The end user and the hosting organization can send non urgent messages through the system.

The device has a CE-mark. The device is a Class IIa medical device (Medical Device Directive (MDD) 93/42/EEC).1

The manufacturer of the product is Kaiku Health Oy.1

The company has an ISO 13485 quality management system in use.1

Additional information

Language
  • English
  • Finnish
  • Swedish
  • German, French
Certificates
  • CE-marked
  • Medical Device, level II a MDD
Quality control
  • ISO 13485
Manufacturing/Distribution in Finland
Kaiku Health Oy
https://kaikuhealth.com/

Conclusion 23.6.2020

The product meets the assessment criteria mainly

The Kaiku Health service is suitable for monitoring the well-being of a patient with cancer during and after active cancer treatments. The service can help the patient manage their symptoms and get treatment when severe symptoms occur.

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

Assessment fields

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