Cardiac Monitoring Platform for Wearable Health Technology

The Client

Founded in 2016 by two cardiologists at the University of Pittsburgh, Everbeat began with an engineering prototype that enabled accurate heart recordings using dry electrodes in a compact, wearable form factor. Over the following years, the founders worked to miniaturize this technology into a practical device, ultimately developing it into a ring that could provide continuous, comfortable cardiac monitoring.

Having successfully created their prototype ring by 2021, Everbeat was ready for the next phase: building the software solution that would make the device practical for patients and doctors. This entailed developing a platform that could analyze the cardiac data collected by the ring to predict events, alert healthcare providers to potential issues, and give patients actionable insights into their heart health. With the global digital health market projected to grow from $313 billion in 2024 to $2.19 trillion by 2034, and wearable cardiac devices growing at 12% CAGR, Everbeat moved forward with their platform development to capitalize on this growth.

Building this platform meant integrating their innovative ring hardware with sophisticated data analysis software and healthcare provider dashboards—all while meeting strict medical device regulations. Based on successful collaboration with Binary Studio on previous projects, Everbeat's CTO, Greg Eoyang, reached out to us to assemble the engineering team for creating this comprehensive platform.

This is the third time I've used Binary Studio, and each time they've delivered with quality and reliability.

Beyond their impressive development skills, flexibility, and dedication to the deliverables, Binary Studio’s team showed a commitment to the project as if they were part of our company.

Cardiac Monitoring Platform for Wearable Health Technology-1

Greg Eoyang

CTO

Cardiac Monitoring Platform for Wearable Health Technology-2 USA

Objectives

Transforming Everbeat's cardiac monitoring prototype into a complete healthcare ecosystem required our engineering team to simultaneously deliver consumer-grade user experience and medical-grade reliability while preparing for FDA regulatory approval across three essential objectives:

01

Cross-Platform Healthcare Ecosystem Development

Build a comprehensive digital health platform from scratch, featuring React Native mobile apps and React web dashboards that seamlessly capture clinical-grade ECG data from wearable devices, process it through traditional and AI algorithms, and deliver actionable insights with real-time synchronization across all interfaces.
02

Medical-Grade Reliability and FDA Compliance

Develop robust backend infrastructure with FastAPI and PostgreSQL that maintains full functionality without internet connectivity, implements enterprise-grade security with HIPAA compliance, and integrates comprehensive clinical workflow tools to support both patients and medical professionals.
03

FDA Submission Readiness and Regulatory Framework

Execute development under startup-style deadlines while maintaining rigorous documentation and design controls required for medical device approval, implementing quality processes including: comprehensive traceability, cybersecurity measures, and regulatory compliance frameworks to prepare for FDA submission and market launch.

End-to-End Healthcare Platform Development

Rely on us to build medical wearable apps that deliver clinical-grade monitoring, ensure robust patient data security, and meet stringent regulatory compliance.

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Solution and Outcome

Binary Studio’s collaboration with Everbeat began with a team of two developers and later expanded to include an additional engineer as the platform’s complexity and regulatory requirements became more apparent. Our approach combined rapid startup development with the meticulous documentation and design controls required for medical device approval.

AWS

React Native

React

Vite

FastAPI

PostgreSQL

TypeScript

Auth0

Docker

WatermelonDB

Python

Stage 1
Foundation and Medical Device Integration
The team built a React Native cross-platform health monitoring application with sophisticated medical device integration capacity. It was designed to meet clinical standards while remaining user-friendly.
Key mobile app features:
- 100% offline functionality for critical features with sophisticated conflict resolution, ensuring medical reliability in low-connectivity environments
- Autonomous PPG monitoring every 30-240 minutes, enabling continuous health tracking without user intervention
- Real-time ECG capture capabilities with clinical-grade accuracy
- Multi-stage sleep analysis identifying Light, Deep, REM, Wake, and Nap phases
- Comprehensive activity tracking, including steps and calorie burn calculations
Parallel to mobile development, we created a React-based clinical interface specifically designed for healthcare providers, incorporating patient management systems, advanced ECG analysis tools, and clinical workflow optimization for study management, facility management, and patient care coordination.
Stage 2
Robust Backend and Medical Signal Processing
The backend development utilized FastAPI with PostgreSQL for robust healthcare data processing, implementing patient data management, device synchronization, enterprise authentication through Auth0, and medical data processing capabilities with AI integration.
A specialized ECG Alignment Tool was developed using React and Python for ECG waveform alignment and comparison, completing the medical signal processing capabilities in just one month—a testament to our team's deep understanding of both technical requirements and the medical domain.
Architectural decisions supporting healthcare compliance:
- React Native for cross-platform development with native Bluetooth Low Energy support
- FastAPI + PostgreSQL, combining Python's medical/scientific ecosystem with performant APIs and HIPAA-ready data handling
- AWS Cloud Infrastructure using Lambda for serverless processing, RDS for managed PostgreSQL, and S3 for secure file storage, with multi-environment deployment across local, development, staging, and production
- Auth0 ensures secure, compliant authentication with role-based access control
- WatermelonDB provides local-first database functionality crucial for medical reliability
- Docker + Microservices enabling modular service design and isolated deployments
These technology choices are critical in healthcare, where data breaches averaged $9.8 million per incident in 2024 and HIPAA violations can carry penalties up to $1.5 million annually.
Beyond security and compliance, operational efficiency was equally prioritized through strategic DevOps optimization. The team implemented a custom GitHub Actions pipeline with self-hosted Mac Mini runners, eliminating the $300-400 monthly costs of cloud-based iOS builds while maintaining consistent deployments across local, development, staging, and production environments.
Stage 3
FDA Preparation and Regulatory Compliance
As the platform neared completion, our focus shifted toward securing regulatory approval. The team strategically adapted to the preparation requirements, with our lead developer providing dedicated support throughout the final month of FDA submission readiness.
Regulatory Deliverables:
- Production-ready status for FDA submission achieved
- Rigorous documentation incorporating comprehensive design controls
- Complete traceability system via Greenlight Guru throughout the development process
- HIPAA compliance implemented across all platform components
- Cybersecurity measures meeting FDA's 2023 Cybersecurity Guidance requirements

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Production-Ready Healthcare Platform

What began as an engineering prototype has evolved into a comprehensive digital health platform positioned to transform cardiac care. The Everbeat platform represents a significant advancement in digital health monitoring, successfully combining consumer-friendly mobile technology with clinical-grade healthcare capacity.
Binary Studio's expertise in healthcare compliance, medical device integration, and scalable architecture proved essential in delivering a platform that meets both patient needs and clinical requirements. Our thorough approach—including external security audits with zero critical issues reported, optimized CI/CD pipeline with multi-environment deployment, complete test coverage spanning unit, integration, end-to-end, and performance testing, and meticulous FDA documentation—ensured the platform's readiness for healthcare deployment and positioned Everbeat for success in the rapidly expanding $2.19 trillion digital health market.
The successful completion of this FDA-ready platform demonstrates Binary Studio's track record to deliver complex, regulated healthcare solutions while maintaining the agility and speed that startups require. Our end-to-end product delivery approach transformed a healthcare prototype into a fully functional, production-ready ecosystem including mobile applications, web dashboards, backend infrastructure, and compliance frameworks.

About Binary Studio

Binary Studio is a boutique software development company, regularly praised for its unique blend of engineering excellence and product ownership that enables its clients to build robust and scalable software products.
With our development team made up of top 0.5% international tech talent, we build web and mobile platforms using Node.js, .NET, React Native, Flutter, and integrating AI and ML. We also offer full-cycle QA and project management services to ensure the efficient delivery.
Our clients see us as a trusted partner dedicated to turning visions into great products. This is proven by 200+ delivered projects, more than two decades of business excellence, and stellar customer reviews.

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