On December 23, 2024, Vitalera achieved a significant milestone by successfully completing the first phase of the rigorous reclassification process to MDR Class IIa. This achievement was backed by outstanding clinical trial results and supervised by Ente Certificazione Macchine Srl, a notified body (No. 1282) for the new European Medical Devices Regulation (MDR), designated by Italy's Ministry of Health, with the notification published on the European Commission’s NANDO portal on October 14, 2022.

This milestone marks the culmination of over two years of dedicated work, involving collaboration with more than seven hospitals and positioning vitalera as an interoperable medical remote patient platform capable of managing any disease, regardless of the clinical condition.

The clinical trials focused on monitoring patients with chronic diseases, demonstrating the transformative potential of Vitalera's platform. The VAL-HIC clinical study, led by the Hospital Clínic de Barcelona, revealed that telemonitoring with the Vitalera platform is as effective as standard care in improving quality of life and promoting self-care among patients with heart failure (HF). The platform empowers patients, enhances clinical outcomes, and supports healthcare professionals by streamlining care delivery. It also alleviates the burden on doctors and caregivers by automating the detection of anomalies in patient data, accelerating decision-making, and reducing hospital visits.

Through this study, Vitalera validated the platform effectiveness for patients and the digital platform’s value for medical professionals by measuring improvements in patients’ quality of life and reductions in critical health events.

These exceptional findings highlight the potential of telemonitoring not only to revolutionize the management of all diseases, particularly chronic conditions, but also to proactively predict and address health challenges. As ongoing research continues, Vitalera aims to expand its impact across various clinical settings by integrating new sensors and addressing broader patient populations. This effort paves the way for remote patient monitoring to become a cornerstone of accessible and effective healthcare. Additionally, vitalera offers an API for white-label integration of its functionalities into third-party platforms, such as hospitals, insurers, clinics, or other telemedicine companies, facilitating seamless development and integration.

This achievement also positions Vitalera’s solution to secure Class IIa certification (Medical Device Regulation) in the near future, further solidifying its reputation as a reliable and compliant healthcare innovation.

For more information, consult the clinical trials: https://clinicaltrials.gov/study/NCT05825755‍