HeartShield

HeartShield is your personalized digital program designed to help you manage and lower your blood pressure through tailored diet and exercise plans. Our evidence-based approach combines the latest in hypertension research with behavioral science to guide you toward healthier lifestyle choices. Whether you're looking to reduce salt, increase potassium intake, get more active, or are not sure where to start, HeartShield provides the tools and support you need to take control of your heart health.
Key Features:

Personalized Action Plans: Receive daily tasks tailored to your lifestyle and progress, helping you make meaningful changes in your diet, exercise, sleep, stress, and alcohol habits.
Educational Content: Learn about all aspects of managing blood pressure via lifestyle, including the impact of salt, the benefits of potassium, and other essential topics with our easy-to-understand resources.
Progress Tracking and Analytics: Monitor your blood pressure, activity levels, and dietary habits, with detailed analytics to see how your efforts are paying off.
Reminders and Alerts: Stay on track with timely reminders for medication, blood pressure measurements, and daily goals.
Interactive Engagement: Quizzes, progress reports, and interactive tools keep you motivated and engaged throughout your journey.

Start your journey to better heart health with HeartShield today!
This app uses Apple HealthKit to track steps, blood pressure, and weight data for personalized health guidance. It also connects to Omron blood pressure monitors via Bluetooth for automatic data sync.
REGULATORY INFORMATION & SAFETY DISCLAIMER
Medical Device Status HeartShield is a CE-marked Class I Medical Device under the European Medical Device Regulation (MDR 2017/745).
UDI-DI: 539155069HEARTSHIELD001GF
Manufacturer: NazataBio, Clonmellon, Co. Westmeath, C15 VK71, Ireland.
Jurisdiction: HeartShield is a CE-marked medical device cleared for use in the EEA and UK. It connects to Omron Bluetooth blood pressure monitors, which are independently CE-marked Class IIa medical devices. HeartShield does not measure blood pressure; all readings come from these independently regulated devices.
Intended Purpose HeartShield is intended to support adult patients (18+) diagnosed with essential hypertension (ICD-10: I10) through education, self-monitoring, and lifestyle tracking.
IMPORTANT SAFETY WARNINGS
Not a Diagnostic Tool: This application does not diagnose hypertension or any other medical condition. HeartShield is designed to complement, not replace, professional medical care. Consult your doctor before making changes to your treatment plan. The information provided in this app is not intended for medical diagnosis or to replace treatment your doctor has prescribed to you
Not a Measurement Device: HeartShield does NOT measure blood pressure. You must use a separate, validated blood pressure monitor to obtain readings.
Medication Safety: Never stop or change your prescribed medication dose based on data in this app without consulting your doctor.
Emergency: In the event of extremely high readings accompanied by symptoms (chest pain, shortness of breath), seek immediate emergency medical care.
Contraindications (Who should NOT use this app)
Users under 18 years of age.
Pregnancy: This device is not intended for use during pregnancy. Please consult your obstetrician for pregnancy-specific management.
Data Privacy All health data is encrypted and hosted in Frankfurt, Germany (EU) in compliance with GDPR.
For full Instructions for Use, please visit: https://heartshield.nazatabio.com/HeartShield-IFU-1.0.0.pdf