02/07/2025

Healthentia

 

CASE STUDY

 

 

 

 

Background

In 2020, in the early phases of the pandemic, Innovation Sprint ’s founder recognised the growing need for point-of-care diagnostics and remote patient health monitoring. With their software Healthentia, which at the time was primarily used in clinical studies as an ePRO (electronic Patient Reported Outcome) solution, they envisioned a broader impact: an AI-powered platform that would evolve into a certified Software as a Medical Device (SaMD) for remote patient monitoring (RPM) and digital therapeutics (DTx). This vision included not only patient self-reporting but also real-time data collection via wearables, lifestyle coaching, and clinical insights—all integrated through a clinical dashboard for healthcare professionals. In 2025, Healthentia became the first Belgian RPM/DTx SaMD to receive market approval under the EU MDR (Class IIa)—a major milestone that validated its clinical, technical, and regulatory excellence.

 

What we did

We began working with Innovation Sprint in 2020, reviewing their quality system against ISO 13485 and assessing the Healthentia product in terms of documentation, clinical claims, and its roadmap toward CE marking—initially under the MDD. 

Together with the company’s QA and product teams, we mapped the regulatory strategy, led a gap analysis, and helped shape the technical documentation needed for certification. Our collaboration extended through the MDR transition, where Healthentia underwent a complete transformation—from a data collection tool to a validated software supporting chronic disease patients in real life. 

The MDR process, which culminated in 2024, included evidence-backed justifications for indications, risk analysis, usability engineering, and clinical performance. 

Today, Healthentia is deployed in over 10 European countries, supporting various use cases such as oncology, heart failure, COPD, and diabetes. It also features virtual coaching, real-world data analytics, and a regulatory foundation robust enough to support ongoing FDA 510(k) clearance efforts. Healthentia is also one of the first reimbursed digital health solutions by RIZIV/INAMI in Belgium, a pioneering step toward value-based care in digital medicine.

 

 

 

 

 

 

 

 

 

 

 

Visit Healthentia website and Innovation Sprint website for more details.

 

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