Patients with chronic heart failure are often readmitted to hospital, and following them at home can catch problems earlier. FollowHealth, a company founded in Barcelona in 2018 and known first as HumanITcare and now as vitalera, built a remote monitoring platform that connects patients' blood pressure cuffs, scales and wearables to their hospital team, with alarms when readings go wrong.
The European Innovation Council granted €2,438,800 towards a €3.59 million project to add artificial intelligence, run clinical studies and certify the platform as a medical device. The studies were completed in Spain and Romania. The certification, a Class IIa rating under the EU Medical Device Regulation, was still in process when the project ended in June 2025, and the company has meanwhile shifted towards selling its technology as an API to other health apps.
Company file
- Legal entity
- FollowHealth SL, Spain (VAT ESB67197384)
- Brand
- vitalera (formerly HumanITcare)
- Founded
- April 2018, Barcelona
- Co-founders
- Nuria Pastor (CEO), Unai Sánchez (CTO)
- Offices
- Elgoibar and Barcelona (Spain); Philadelphia (US)
- Products
- Remote monitoring platform, API and SDK for devices and wearables
- EIC project
- HumanITcare, 1 Jul 2022 to 30 Jun 2025
- EIC funding
- Blended finance
Where vitalera Stands Today
The old HumanITcare website now carries a banner, "Ahora somos vitalera", and points to vitalera.io. There the company presents itself as a provider of APIs, SDKs and AI agents for remote monitoring, lists clients including Hospital Clínic de Barcelona, Torrevieja University Hospital, Maastricht University and Harvard Medical School, and claims more than a million users. In January 2026 it announced Spain's high-level security certification, ENS Alto, and a breast cancer monitoring project with Maastricht UMC+.
Its regulatory status is less clear. In December 2024 vitalera announced it had completed "the first phase" of reclassification with the Italian notified body Ente Certificazione Macchine, positioning it to secure Class IIa certification "in the near future". The CORDIS report at project end still describes the certification as underway. Its homepage lists "MDR Class IIb" among its certifications. We found no certificate published for either class.
The Technology: Devices to Dashboard
The platform collects readings from connected medical devices and consumer wearables, including Garmin devices through a partnership the company announced, plus patient questionnaires, and presents them to clinicians with alerts. During the EIC project, according to the CORDIS report, it built first AI algorithms to prioritise patients and manage alarms. Usability scores were 80.8 for clinicians and 69.8 for patients.
"HumanITcare increased patients' quality of life, enabling them to perform self-care tasks more effectively while feeling secure."
Juan Antonio Franco, nurse, Hospital Torrevieja, on the company's impact pageWhat the EIC Project Promised, and What CORDIS Shows
The project, which ran from July 2022 to June 2025, completed two clinical studies: VAL-HIC, an interventional trial at Hospital Clínic de Barcelona, and DHEART, an observational study. CORDIS reports a "47% improvement in quality of life and 23% improvement in self-care behavior". The company's own summary of VAL-HIC says the platform matched standard care for heart failure patients in improving quality of life and self-care, which is a different claim from outperforming it. ISO 27001 certification was achieved; MDR Class IIa certification was in progress.
- Clinical validationDeliveredVAL-HIC and DHEART completed.
- AI prioritisation and smart alarmsInitialFirst algorithms, per CORDIS.
- MDR Class IIa certificationNot confirmedIn process at project end; no certificate published.
- International expansionStartedUS office; Maastricht project.
What Has Happened Since the Award
The Money
The company's about page lists €360,000 in Spanish government grants in 2020 and European Commission support; the HumanITcare site cites NextGenerationEU funding through Spain's recovery plan. In its MIT Solve profile the company says that "in 2022 we received the EIC Accelerator grant and secured the investment of the EIB", and an equity-free grant from Google.org for oncology research; it gives no amounts. We found no announced venture round and no EIC Fund investment. Spanish company accounts were not accessible for this article.
What cannot be checked
Which MDR certificate vitalera actually holds, how many hospitals pay for the platform, and the company's revenue are not public.
Why Europe Should Care
Europe's health systems are under pressure from ageing populations and chronic disease, and remote monitoring is one way to treat more patients at home. Certification under the MDR is what allows such software to be used as a medical device, and it is the step the EIC project did not complete.
What the project promised
An interoperable, smart remote monitoring platform for chronic patients, clinically validated and certified.
What the record shows
Two completed studies and a rebrand towards APIs, but no published MDR certificate and inconsistent public claims about its class.
The Verdict
Validated in hospitals, unclear on paper
The EIC project produced clinical evidence and a better platform, and the company is visibly active in 2026. But the certification that was a core goal was not finished by the end of the project, and vitalera's own pages disagree on which class it holds. A company selling medical monitoring should make that status easy to verify.
vitalera has not been asked for comment for this article. It is based entirely on public records, company statements and EU project data, linked throughout.
