Cardiometabolic · Hypertension
Amicomed
Hypertension Program · Newel Health
CE-marked digital solution that helps patients lower blood pressure through behavioral coaching and remote monitoring.
Regulatory class
MDR Class IIa
Registration
IT-MF-000028500
Certification expiry
2029-07-16
Commercial pilots
Active in Italy
The problem
Hypertension: a silent epidemic.
Millions of people live with hypertension, often silently. Blood pressure fluctuates, is hard to track meaningfully, and insights come too late. Patients feel lost between doctor visits. Physicians are overwhelmed with disconnected data.
1.28B
Adults (30–79 years) with hypertension worldwide
42%
Of diagnosed individuals receive treatment
#1
Risk factor for cardiovascular disease globally
~10%
Of global healthcare expenditure attributed to hypertension
4–5×
Increased stroke risk from uncontrolled hypertension
2–3×
Increased heart attack risk from uncontrolled hypertension
Sources: WHO, The Lancet, American Heart Association
The solution
What is Amicomed?
Amicomed is a CE-marked Software as a Medical Device (SaMD) (Class IIa under EU MDR), built to support the non-pharmacological management of hypertension through structured digital interventions.
While connected devices capture clinical-grade blood pressure data, Amicomed transforms it into a continuous care experience aligned with medical guidelines and behavioral science.
Amicomed, powered by the Pascal algorithm, is a non-invasive SaMD intended to assist individuals with hypertension, or those at risk, in the monitoring and interpretation of their blood pressure and heart rate over time.
Key attributes
- CE-marked SaMD with defined therapeutic scope under EU MDR
- Uses validated clinical logic to interpret blood pressure patterns
- Delivers structured, personalized lifestyle support aligned with international hypertension guidelines
- Modular integration via hCore platform with secure API
- ISO 13485 certified, GDPR and HIPAA compliant
- Ready to integrate into connected BP devices and health system environments
Clinical evidence
Validated at scale.
170,000+
Measurements
2,800+
Subjects
755
Enrolled in lifestyle intervention (3 months)
| Outcome | Result |
|---|---|
| Mean reduction in systolic BP (uncontrolled hypertensive) | ~7.9 mmHg |
| Reduction in overall population | ~4.7 mmHg |
| Best cases | ~20 mmHg |
| More people with ideal BP | +50% |
| Reduction in MACE (Major Adverse Cardiovascular Events) | −30% |
Results from a case control study and a larger validation study.
Peer-reviewed by
European Society of Hypertension · American College of Cardiology · American Society of Hypertension · American Heart Association · European Society of Cardiology
Go-to-market
Entering the market across key channels.
Amicomed is MDR Class IIa certified and actively entering the market as a candidate digital therapeutic for hypertension.
| Channel | Approach |
|---|---|
| Clinical care | Prescription-based use in outpatient settings |
| Public health | Collaborations in emerging markets |
| Pharma | Integrated drug + digital partnerships |
| Insurance & employers | Inclusion in chronic care programs |
| B2C | Controlled release in select markets |
Interested in partnering on Amicomed?
Whether you want to license Amicomed, integrate it into your care programs, or explore co-development opportunities, we are open to conversations at any stage.
info@newel.health · Newel Health Srl, Largo Abate Conforti, 84121 Salerno, Italy