The MyDiagnostick
MyDiagnostick, a MDD Class IIa medical device, is intended to discriminate atrial fibrillation (AF), a common arrhythmia, from normal cardiac rhythm.
MyDiagnostick is very easy to use and has no buttons or parameters to be set.
When picking up MyDiagnostick the device automatically switches on and is ready for use. After only one minute of ECG recording (Lead I), AF diagnosis is completed and shown to the patient or physician. MyDiagnostick will turn either red or green to indicate AF or non-AF. After completion, MyDiagnostick will automatically switch off. This is in contrast with current Holter and event recorders that use ECG skin electrodes connected by wires to the recording device worn on the belt of the patient. After placement of the electrodes and connecting the wires, the device must be set and started. This requires assistance by a medical professional and prohibits long-term autonomous use by the patient.
The recorded ECG is of a high quality and the AF detection algorithm is highly sensitive and specific. MyDiagnostick is able to record and store 140 ECG's.
The ECG strips stored in MyDiagnostick can be retrieved through an USB connection by the physician, enabling clinical confirmation and documentation of AF.
MyDiagnostick can be used by general practitioners to detect AF in their patient population.
Also when the doctor suspects that AF is the cause of a patients symptoms or vague complaints, MyDiagnostick will allow to perform measurements outside of the doctor’s office for a longer period of time. The patient can use MyDiagnostick at home, at the office or anywhere at any time during the day. So MyDiagnostick can be used to screen for silent AF.
Furthermore MyDiagnostick can be used also by care providers like cardiologists, neurologists, nurses and pharmacists, for example to assist in diagnosing the underlying cause of a stroke.
After only one minute, AF outcome is displayed by turning either red or green and is shown to the patient or physician by MyDiagnostick.
After use, the device will switch off automatically. This is in contrast with current Holter and event recorders that use ECG skin electrodes connected by wires to the recording device.
MyDiagnostick has a diagnostic function for detection of AF build into the device. MyDiagnostick does not depend on any infrastructure and therefore can be used anywhere, anytime. It is required that a medical doctor confirms the outcome of MyDiagnostick based on the stored ECGs in MyDiagnostick.
The cost related to a 24 hour Holter ECG recording including patient guidance and analysis of the result has been estimated between US$152 and US$168.
In contrast to Holter recording, MyDiagnostick can be used for long term monitoring (months) of several patients with minimal cost for patient guidance and external diagnostics and additional logistics.
The clinical applications of MyDiagnostick for the general practitioner are in the area of screening for AF and for stroke reduction. The Cardiologist can for example detect AF recurrences in Rhythm Control and also screen for AF in case of decompensation in Heart Failure.
Therefore we are convinced that MyDiagnostick is a valuable extension to the current diagnostic devices on the market today. MyDiagnostick will have a higher performance for detection of patients with episodes of AF.
We emphasize that MyDiagnostick does not exclude Holter analysis. Holter analysis can be used in combination with MyDiagnostick for first 24 hours continuous monitoring of ischemic stroke patients, followed by a longer (months) period of monitoring by MyDiagnostick