An old man visiting his general practitioner is asked to hold a small metal tube in his hands. After a minute the green light on the metal surface goes on. The patient has just undergone an ECG scan with the device called MyDiagnostick, which was developed specifically for the screening of widespread but under-diagnosed condition – atrial fibrillation. This condition is a common arrhythmia that increases the risk of heart failures and strokes if left untreated. However, quite often the patients do not receive the preventive treatment early enough because atrial fibrillation is often asymptomatic, and its identification and detection require long-term ECG monitoring. “40% of cases of atrial fibrillation are not present all the time. Atrial fibrillation event lasts for a couple of minutes and then it goes away for two-three weeks, so you have to be lucky to catch it,” says Vincent Larik, the director of Applied Biomedical Systems. And that is why his company based in Brightlands Maastricht Health Campus developed and eventually started producing a device that allows easy screening for atrial fibrillation in the risk groups.
The first MyDiagnostick was created in 2011 at the request and in cooperation with cardiologists. In 2012 MyDiagnostick received its CE-mark as a medical device. “The device is developed for the medical professionals – general practitioners and specialists like cardiologists or neurologists,” says Vincent Larik. “Some individuals purchased the device for home use as well, but we had asked them to consult their general practitioner first.”
Atrial fibrillation is very common among people aged 65 and older, so MyDiagnostick was designed to be user-friendly for this target group. “The patient does not have to do anything with the device except for holding it in their hands,” says Larik. “The patient should sit with as little movement as possible for a minute and hold the device in their hands until the light goes on – red if the atrial fibrillation has been detected or green if it was absent. After that, the device can be put away till the next time. The procedure can be repeated as often as the patient wants it (up to 140 times). The device records the ECGs and stores all of them in its memory. You don’t need any infrastructure for this device, neither you need to use a smartphone or a computer with it. The patients don’t even have to charge the device. In a couple of weeks, the patient can go back to the GP, hand in MyDiagnostick and then the GP can read the ECGs.”
MyDiagnostick is used by general practitioners in the Netherlands. “A care group of general practitioners in Groningen has been running a programme of preventive screening for four years aimed at finding the people with atrial fibrillation and treating this condition in order to lower the expenses for the treatment of more dangerous consequences of atrial fibrillation later. If atrial fibrillation is detected early, the patients go to the specialist in the hospitals less often and can remain with the family doctors,” says the director of Applied Biomedical Systems. MyDiagnostick is also used in other European countries: practical studies of the device aimed at collecting more statistical information have been recently carried out in the pharmacies of Aachen and are being conducted now in several pharmacies in Pessac (France). In these studies, the patients of 65 and older were offered a measurement using MyDiagnostick.
At present MyDiagnostick is a fully validated and optimised device. Every three years it undergoes the re-evaluation as required by the European regulations for the medical devices with CE-mark. When asked about the further technical development of the device, Vincent Larik says that in the future Applied Biomedical Systems might expand the range of heart conditions detectable with MyDiagnostick.