FibriArt - Wearable ECG Patch

A smart medical device designed to capture medical-grade ECG readings directly on your smartphone.

FibriArt records a single-lead ECG, assisting patients and physicians with clear, dependable insights into heart rhythm.

Preparing for FDA 510(k) submission

Why FibriArt ?

FibriArt-Is built to make ECG recording simple, reliable, and comfortable.

Comfortable Design

A lightweight and discreet patch with minimal skin preparation, designed to fit naturally into daily life.

Simple Connectivity

User-friendly apps with wireless syncing via WiFi or Bluetooth allow easy access and sharing of ECG data.

Clear Heart Rhythm Insights

The device provides ECG rhythm strips, heart rate (HR), and R-R interval (RRI) data. When used with a compatible smartphone or tablet application, the device displays the recorded ECG waveform and generates a report for review.

Flexible Options

Available in four models, FibriArt adapts to different needs-from short-term use to extended wear-making it a practical choice for diverse care settings.

Main Features of the FibriArt^TM Wearable ECG Patch

Lightweight & Discreet ECG Patch:

FibriArt-Is designed to be small, comfortable, and easy to wear, allowing users to record heart rhythms during everyday activities without interruption.

Water-Resistant ECG Device :

Built with durability in mind, the wearable ECG patch continues to function reliably during exercise, sleep, or even while showering.

7-Day Battery Life for Continuous ECG Recording :

A long-lasting battery ensures up to one week of uninterrupted ECG data recording, with simple recharging for convenience.

Extended ECG Recording for Long-Term Use :

The FibriArt-X model offers up to 28 days of continuous heart rhythm recording, providing valuable long-term ECG insights for a deeper heart health understanding.

Advanced Comfort with Textile Conductive Technology :

Using printed conductive ink on soft fabric instead of rigid metal contacts, FibriArt reduces skin irritation and improves comfort during extended wear.

Your Heart Health, Anytime, Anywhere

Access your ECG patches on mobile, desktop, and laptop platforms for consistent heart health tracking wherever you go.

FAQs

1.What is the accuracy of the ECG signal compared to standard hospital ECG machines?

FibriArt^TM delivers clinical-grade ECG signals with precision comparable to standard 12-lead hospital ECG systems (Lead to Lead comparison), using advanced signal filtering and noise suppression algorithms. The device is validated to detect Heart Rate and RR interval with high sensitivity and specificity, and provides reliable performance even during patient movement.

2. Is the ECG interpreted in real-time?

Yes. FibriArt^TM offers real-time ECG interpretation using onboard algorithms and AI-assisted backend processing. Abnormalities are instantly flagged and automatic alerts can be sent to clinicians via the remote portal or app.

3.Is the device easy to use for non-technical staff or patients?

Absolutely. The device is designed to be plug-and-play, requiring minimal training. Patients can self-apply the patch with easy-to-follow instructions, and clinicians or caregivers can access data through a user-friendly dashboard or mobile app.

4. What is the battery life of the device?

Depending on the monitoring duration selected, the device supports:
- Short-term monitoring (1-2 days): Rechargeable battery lasting up to 7 continuous days
- Extended monitoring (up to 28 days): Option to hot-swap battery module with replaceable patch

5. Is the device FDA-approved and CE-marked?

FibriArt^TM is currently in the process of obtaining FDA 510(k) clearance and CE marking under Class IIa for medical-grade wearable ECG monitoring. Regulatory compliance with IEC 60601-1, IEC 60601-2-47, ISO 10993, IEC 62304 and GDPR/HIPAA standards is also ensured.

6. Has the device been validated in clinical trials or studies?

Not yet. However, the FibriArt^TM system has been developed in full compliance with IEC 60601-2-47 guidelines for ambulatory ECG monitoring devices, ensuring medical-grade safety and performance. It is currently undergoing extensive clinical validation through multi-centre studies and pilot deployments across hospitals and cardiac care centres. These studies include comparative evaluations with conventional Holter systems, focusing on signal accuracy, patient compliance, and diagnostic yield.

7. What is the pricing structure for the product?

We offer flexible pricing models including:
- Pay-per-use for each patient scan/report
- Subscription model for remote monitoring services and analytics platform access Detailed pricing can be customized based on deployment volume and use case.

8. Why would patients buy the product directly since once the indication is detected, the device becomes no use to them?

Direct purchase may not always be practical for patients. Instead, we offer value through rental and physician-prescribed usage models. For those requiring frequent or episodic monitoring (e.g., AFib, post-stent, or home care), the device can be reused over time under clinical guidance.

9. Can it be available on a rental model since you cannot directly target patients to purchase the device?

Yes. FibriArt^TM is available through a rental model via partner clinics, hospitals, or home health providers. This allows patients to access high-quality cardiac monitoring on-demand without bearing the full cost of ownership.

10. What is the idea behind FibriArt-X since it is very rare when the patient is monitored for more than 7-8 days?

FibriArt-X is designed for extended monitoring up to 28 days, addressing cases where arrhythmias are infrequent, asymptomatic, or episodic and may not appear in shorter durations. It is especially useful for:
- Cryptogenic stroke evaluation
- Pre/post-ablation monitoring
- Atrial fibrillation surveillance in high-risk populations

11. What makes this product stand out since there are many similar devices in the market and still hospitals/clinics are using conventional Holter systems?

FibriArt^TM stands out by combining clinical accuracy, patient comfort, and remote intelligence into one unified system:
- Wireless, patch-based design with no cables or bulky recorders
- Seamless integration with hospital EMRs and remote portals
- Real-time alerts, AI-based analysis, and auto-reporting features
- Customizable monitoring durations from 2 minutes to 28 days
- End-to-end support including rental, logistics, cloud storage, and compliance Hospitals continue using conventional Holters due to legacy workflows. FibriArt enables a smooth transition to modern monitoring while enhancing patient satisfaction and diagnostic yield.

FibriArt - Wearable ECG Patch

Why FibriArt ?

Why FibriArt ?

Comfortable Design

Simple Connectivity

Clear Heart Rhythm Insights

Flexible Options

Main Features of the FibriArtTM Wearable ECG Patch

Your Heart Health, Anytime, Anywhere

FAQs

Main Features of the FibriArt^TM Wearable ECG Patch