Proven clinical evidence. Proven cost-effectiveness.
Facts and studies
From the first concept to the evaluation and continuous refinement, Preventicus has been working closely with cardiologists, scientists, engineers, patients, and population health experts. For us, the guiding principle has always been on matching medical knowledge with what digital technologies offer today.
Scientific research demonstrates the legitimacy of the use of the Preventicus® Heartbeats App and Preventicus Nightwatch® for stroke prevention. In the most recent international studies on over 1,300 participants (Watch AF and Detect AF Pro), it was shown that the app detected atrial fibrillation (AF) with an accuracy of approx. 96%. The positive predictive value was over 99%, which means that two independent cardiologists subsequently confirmed AF recognized by the Preventicus Heartbeats App in over 99% of the cases.
Results of the most recent scientific studies published:
Detection of atrial fibrillation with a smartphone camera: first prospective, international, two-center, clinical validation study (DETECT AF PRO)
N. Brasier, C. J. Raichle, M. Dörr, A. Becke, V. Nohturfft, S. Weber, F. Bulacher, L. Salomon, T. Noah, R. Birkemeyer, J. Eckstein. Detection of atrial fibrillation with a smartphone camera: first prospective, international, two-centre, clinical validation study (DETECT AF PRO). EP Europace, , euy176, https://doi.org/10.1093/europace/euy176
ClinicalTrials.gov Identifier: NCT02270112
AF detection using smartphone apps
Detection of premature beats using smartphone-based pulse wave recordings
Smart detection of atrial fibrillation
Validation of a New Heart Rate Measurement Algorithm for Fingertip Recording of Video Signals with Smartphones
Cutting-edge research projects by the European Union
Preventicus is supported by two of the European Union's Horizon 2020 research projects (SME Instruments Phase II and Eurostars). Horizon 2020 is the European Union's framework program for research and innovation. This funding program aims to build an EU-wide association built on science and innovation and a competitive economy and, at the same time, contribute to sustainable development. The Horizon 2020 funding project (SME Instruments Phase II) "RedStroke" (Reducing Stroke in Europe) enables Europe-wide clinical studies based on Preventicus technology.
RedStroke - Reducing Europe's Stroke Incidence: Highly Cost-effective Population Screening Programs for Atrial Fibrillation Coupled With High Diagnostic Yield Confirmation Services
The RedStroke study is currently being conducted in seven European countries (estimated study completion date: Dec. 31, 2020). In this study, the effect of a smartphone application in detecting AF will be assessed in a double-blind randomized controlled multicenter trial.
For full details, please see https://clinicaltrials.gov/ct2/show/NCT04108884.
A cost-effectiveness analysis model of Preventicus atrial fibrillation screening from the point of view of statutory health insurance in Germany
App as a certified medical device
The Preventicus Heartbeats App is a CE-marked medical device application (class IIa) complying with the essential requirements of the Medical Device Directives (MDD). Clinically validated, the app has the world's highest accuracy in the detection of AF.
Thousands of correctly conducted heart rhythm analyses daily confirm the precision of Preventicus’ superior biosignal-analytic algorithms. Preventicus has ISO 13485 certification – the design, production, installation, and servicing of our medical-grade app meet the highest quality standards. ISO also testifies to continual improvement of our solutions and procedures.