The Basel University Hospital in Switzerland conducted a clinical study on the algorithms programmed into Preventicus Heartbeats. The clinicians examined the extent to which atrial fibrillation can be detected and/or a delineation versus healthy subjects is possible.
In its initial prospective validation, the algorithm correctly classified 90% of all subjects within a two-minute measurement. By extending the measurement time to five minutes, the accuracy could be increased to as much as 95% overall, with a sensitivity and specificity of 95% for detecting patients with atrial fibrillation versus a healthy control group.
The article on this study was published in Europace (the official journal of the European Heart Rhythm Association of the European Society of Cardiology; follow the link to download the publication: Download the paper>>
If you buy the paid full version of Preventicus Heartbeats, the measurement takes 5 minutes and achieves this 95% accuracy.
The one-minute quick test - included in the free version and in the paid full version - still reaches an accuracy of between 70-75%. Ongoing clinical studies are investigating and continually validating the algorithm, in other rhythm disorders as well.
Approved medical product
Preventicus Heartbeats is a (CE-certified) class I medical device that is in conformity with the Essential Requirements of Medical Device Directive 93/42/EEC or its respective national transpositions.
The quality management system in place at Preventicus GmbH is certified according to ISO 13485:2012. This standard provides the framework and specifies the international requirements for quality management systems, particularly those governing manufacturers of medical devices.
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Clinical trials have demonstrated that the algorithm on which this App is based can detect the difference between irregular cardiac rhythms (e.g. atrial fibrillation) and regular heart rhythms with an accuracy of up to 95%. In other words, for example, in only 5% of all cases did the App mistakenly not detect a cardiac arrhythmia (although present) and/or mistakenly classify a normal cardiac rhythm as a cardiac arrhythmia (although absent). The user of this app is hereby made aware of possible misinterpretations, and thereby releases Preventicus from any liability arising from any misinterpretation.
The findings obtained are exclusively intended for information purposes and under no circumstances do they replace personal diagnostics, consultation, care or treatment by medical or other medically trained personnel.
The App is not designed to be an aid in either decision-making for acute states or for real-time monitoring of vital functions: Neither does this App encroach upon any existing guideline-compliant diagnostic pathways or therapeutic measures.
PREVENTICUS and its executive bodies, executives, employees, vicarious agents, partners, affiliates and licensors assume no responsibility whatsoever for decisions made by you based on the information, such as decisions as to whether or not to consult caregivers or accept treatment by medical or healthcare professionals. You hereby waive all and any claims you have or may have in the future against PREVENTICUS and its executive bodies, executives, employees, vicarious agents, partners, affiliates and licensors and herewith declare to hold the aforementioned harmless from any claims, litigation, costs or for any direct or indirect damages arising in connection with the use of the information. This also applies to lost earnings.