We are very proud to share that the MESI mTABLET TBI, our device used for early detection of the Peripheral Arterial Disease (PAD) by measuring the Toe-Brachial Index in patients with non-compressible arteries due to various conditions, was cleared for marketing and sales by the US Food and Drug Administration (FDA) in April 2022. This is our second achievement of this kind: the MESI mTABLET ABI module, used for the Ankle-Brachial Index measuring, was cleared by the FDA in 2020. Consequently, US healthcare professionals now have a diverse tool for comprehensive arterial assessment at primary care level. Their patients can either be examined with the MESI mTABLET ABI (if they have no clinical conditions connected with high PAD risk) or the MESI mTABLET TBI (in the case of comorbidities).
The consequences of the Peripheral Arterial Disease include stroke, coronary heart disease, amputations and even death. According to the American Heart Association (AHA), it affects 8.5 million Americans and over 230 million people worldwide. The AHA Scientific Statement recommends urgent PAD screening for all risk groups, defining ABI (the Ankle-Brachial Index) as “the first-line noninvasive diagnostic method for PAD” .
The ABI has traditionally been measured with the Doppler ultrasound device. However, this method is underused as it is complex and time-consuming. The MESI mTABLET ABI measures the Ankle-Brachial Index in 1 minute; a result indicative of PAD makes a reliable case for a subsequent Doppler investigation by a specialist. This means a more effective and faster discovery of this dangerous disease with simple check-ups at primary care level.
Notably, the ABI measurements are not performed in patients with stiffened ankle arteries; this condition is related to medial artery calcification – a frequent consequence of chronic kidney disease or diabetes . In this case, the 1-minute MESI mTABLET TBI can be used instead.
With both the MESI mTABLET ABI and the MESI mTABLET TBI, the measurement is fully automated. Besides their advanced technology for PAD detection, they both enable instant saving of the measurement results in the digital patient record for easy retrieval and comparison, as well as immediate sharing for a second opinion.
The presence of the MESI mTABLET ABI and the MESI mTABLET TBI on the US market is to provide US healthcare with digital solutions that reduce the administrative workload and the PAD mortality rate with timely diagnosis and treatment.
Our ultimate global mission, however, is to transcend the traditional concept of one-purpose diagnostic devices and isolated measurements in order to provide healthcare with predictive medical assessment. This means that our MESI mTABLET solution will not only combine various digital diagnostic measurements, immediate patient record storage and clinical support tools, but also clinical AI recommendations – all on one device.
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