Preventicus Nightwatch is a clinically validated and MDR-certified medical device (CE IIa) for recording and analyzing heart rate curves with wearables (e.g. Polar Verity Sense). This allows both the heart rate (pulse) and the heart rhythm to be analyzed. Regular use supports the detection and monitoring of sporadic cardiac arrhythmias, especially atrial fibrillation.
Please note that Preventicus Nightwatch App can currently only be used after initialization by medical professionals.
The range of functions and the supported wearables are continuously being expanded and the app extended for different usage scenarios.
Intended purpose
The app is used to detect cardiac arrhythmias in the form of a suspected diagnosis and to determine and characterize the heart rate. This concerns the following cardiac arrhythmias:
- Detection and quantification of absolute arrhythmia with suspected atrial fibrillation
- Detection of extrasystoles and irregular heartbeats
- Determination of the heart rate with indications of bradycardia and tachycardia.
Important notes
All results are suspected diagnoses, not a diagnosis in the medical sense. Suspected diagnoses do not replace personal consultation, diagnosis or treatment by a doctor.
This app must not be used to make decisions in situations that are perceived as life-threatening (e.g. heart attack).
We will be happy to help you with any questions about the app:
Phone: +49 (0) 36 41 / 55 98 45-2
E-mail: [email protected]
Legal information
The Preventicus Nightwatch app is a clinically validated Class IIa medical device certified by TÜV NORD CERT GmbH and meets the essential requirements of MDR Regulation (EU) 2017/745 and its national implementation. The quality management system of Preventicus GmbH is certified according to ISO 13485:2016. This standard formulates and defines the internationally applicable requirements for quality management systems, particularly for medical device manufacturers.