Algorithms of the artificial intelligence DeepRhythmAI (DRAI), used for automatic ECG data analysis, have received extended FDA registration in the USA. With the updated registration, DRAI can be used for ECG data analysis as part of ambulatory telemetry (product code QYX). This is a type of examination that involves remote patient monitoring with continuous ECG recording and automatic data analysis for detecting and recording heart rhythm disturbances. The detected disturbances are sent to the treating physician during the monitoring period. DeepRhythmAI is the only set of algorithms currently approved by the FDA for use under the new QYX product code.
– The USA is one of our most important markets, and the obtained extended approval of DRAI under the new QYX product code in the FDA confirms the highest quality of our breakthrough technology and opens up new possibilities for commercializing our AI algorithms. We are proud to be the first to offer AI algorithms intended for integration with software from other companies, under the new ambulatory telemetry code. This will allow us to offer our cloud software to a new category of customers and thus consistently increase the number of customers in the USA. Of course, we continue our research and development work in the field of artificial intelligence algorithms, constantly expanding our product range and its application in various cardiology procedures – says Przemysław Tadla, board member and CTO of Medicalgorithmics.
DeepRhythmAI (DRAI) is an advanced set of artificial intelligence algorithms, designed to deliver fast and precise ECG analysis results, supporting the diagnosis of heart arrhythmias. The DRAI algorithms were trained on data covering over 3.6 million days of ECG records, making them one of the most advanced of this type in the world. The effectiveness of the technology was confirmed in an independent DRAI MARTINI study, presented in early September at the ESC Congress 2024 in London – the largest cardiology conference in Europe. The study, conducted on a sample of over 14,000 patients, with the participation of over 50 cardiologists from the USA, Canada and Europe, showed that the DRAI algorithms make 14 times fewer errors in detecting critical heart arrhythmias than certified EKG technicians.
In line with the current strategy, Medicalgorithmics is currently focusing on selling diagnostic software with the highest margin and the sale of devices is only an optional offer for customers. In the third quarter of this year, the revenues from the sale of services amounted to PLN 5.2 million, including in the American market they increased by 24% compared to the second quarter and reached PLN 1.2 million. This signifies a recovery of 53% of the revenues from the fourth quarter of 2023. Since adopting the new growth strategy, the company has acquired 13 new clients. The management of Medicalgorithmics expects to acquire a significant customer in the USA still this year, in line with its strategy.
Source: https://managerplus.pl/deeprhythmai-od-medicalgorithmics-z-nowymi-mozliwosciami-precyzyjna-diagnostyka-arytmii-zatwierdzona-przez-fda-95234
