Medical technology company Vitalera, a member of CATALONIA.HEALTH, achieved a significant milestone by successfully completing the rigorous re-classification process to MDR Class IIa certification. This process is backed by the results from its clinical trials, the culmination of over two years of dedicated work, involving collaboration with more than seven hospitals.
The clinical trials focused on monitoring patients with chronic conditions, showcasing the transformative potential of Vitalera’s platform. The VAL-HIC clinical study, led by Hospital Clinic, proved that telemonitoring with Vitalera’s platform is as effective as standard care for improving the quality of life and empowering self-care among heart failure patients. Through this study, Vitalera validated the app’s efficacy for patients and the digital platform’s value for medical professionals by measuring increases in patient quality of life and reductions in critical health events.
Vitalera aims to expand its influence across diverse clinical settings and larger patient populations, paving the way for remote patient monitoring to become a cornerstone of accessible and effective healthcare. This achievement paves the way for CE Mark Class IIa certification and reaffirms the commitment to revolutionizing remote patient monitoring.
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