TECH

Bluetooth for Medical Devices: a Comprehensive Guide

Published: June 2, 2025

18 min read

Sergei Shemshur

Sergei Shemshur

React Native Developer @ Stormotion

Yevhenii Burkovskyi

Yevhenii Burkovskyi

React Native Developer @ Stormotion

Anastasiia Chala

Anastasiia Chala

Rockstar Copywriter @ Stormotion

Connected medical care is no longer a trend. It’s an expectation. From the market and patients.

Bluetooth modules are integrated into almost all medical devices, like smart blood pressure monitors or continuous glucose sensors. Why? Because it’s one of the most affordable, low-power, and mobile-friendly connectivity options.

And while the idea of Bluetooth medical devices is clear, their integration with healthcare apps still raises many questions and concerns.

Medical devices should work reliably across iOS and Android, maintain strong connectivity in hospital and home environments, and meet all regulatory requirements (FDA, HIPAA, GDPR, you name it).

At the same time, you have pressure to launch faster, validate MVP, and deliver a smooth mobile experience without compromising on compliance or quality.

In this guide, we’ll discuss:

  • Why BLE is one of the most reliable protocols for healthcare devices;
  • Successful real-world cases of Bluetooth-enabled medical devices;
  • Benefits and challenges of using Bluetooth for medical devices;
  • The case of our BLE app development company with STEPR, where we integrated a heart rate strap to their stair-climbing machines.

So, let’s start with the basics of Bluetooth connectivity in the healthcare industry!

🏥 Understanding Bluetooth Connectivity in Healthcare

Not all Bluetooth technologies are created equal. And in healthcare app development, choosing the right protocol is one of the most important technical decisions.

What to Choose: Bluetooth Classic or Bluetooth Low Energy

Bluetooth Classic is used for constant, high-throughput data streaming (think about your wireless headphones). Meanwhile, BLE (Bluetooth Low Energy) is optimized for periodic data bursts and low power consumption. And that’s exactly what most connected medical devices need.

Let’s compare BLE vs Bluetooth for wireless medical devices:

Specification

BLE

Bluetooth Classic

Energy Consumption

Ultra-low (ideal for battery-powered devices)

High (designed for continuous use)

Data Transfer Rate

~250 kbps (more than enough for vital sign monitoring)

Up to 3 Mbps

Range

Up to 100 meters (with Bluetooth 5.0+)

Up to 10 meters

Connection Model

Asynchronous, event-driven

Continuous streaming

For most medical devices, whether you're building a wearable ECG patch, a smart inhaler, or a home-use blood pressure monitor, BLE offers the best balance between power efficiency, latency, and mobile integration.

📌 Check the ANT vs Bluetooth comparison guide to find out more about BLE use cases.

Want to turn BLE connectivity into your killer feature?

Let’s talk!

Core Bluetooth Protocols for Medical Devices

When building a clinical-grade app, getting Bluetooth to “just work” isn’t as simple as turning on a module. There’s a lot going on under the hood and selecting the right protocols early on can make or break your app’s performance, power efficiency, and long-term scalability.

According to Bluetooth SIG 2025 report, Bluetooth-enabled device shipments will reach 5.3 billion units in 2025 and rise to nearly 8 billion by 2029.

So, let’s take a look at the key protocols of Bluetooth for medical devices 👇

GATT (Generic Attribute Profile)

GATT is what makes structured data exchange between your device and app possible. Using services and characteristics, GATT sends vital signs like heart rate, temperature, or glucose levels from a medical device to a mobile app.

Examples of GATT in action:

  • Heart rate monitors;
  • Blood glucose meters;
  • Pulse oximeters.

Pro tip: iOS applies stricter limits on background BLE activity compared to Android. That means you should use GATT configuration and connection interval settings to ensure uninterrupted background syncing.

L2CAP (Logical Link Control and Adaptation Protocol)

L2CAP comes into play when your Bluetooth in medical devices needs to transfer more data than fits into a single BLE packet. It handles packet segmentation and reassembly, ensuring that even larger chunks of clinical data get delivered smoothly and reliably.

Think of it as your Bluetooth’s traffic control system, making sure everything streams efficiently under pressure.

SPP (Serial Port Profile)

SPP is a Bluetooth Classic protocol. It mimics serial cable communication but drains power quickly and isn’t well-supported by modern mobile operating systems. That’s why it’s rarely used in medical BLE setups today, unless you’re dealing with legacy hardware.

Regulatory Compliance Considerations

Planning to bring your Bluetooth medical monitoring devices to market? Then it’s not just about making the tech work. It’s about proving it’s safe, secure, and standards-compliant. Whether you're targeting FDA clearance or a CE mark, regulatory planning should start early in development, especially when BLE is your killer feature.

Let’s walk through what your product team should keep in mind: 👇

FDA and EU MDR Classification

If your app receives health data from a medical device via Bluetooth, there’s a high chance it’s considered a medical device, under both FDA and EU MDR regulations.

That means your entire communication stack of Bluetooth in medical devices will be reviewed, including:

  1. How BLE affects your risk analysis;
  2. How you’re ensuring data privacy and security during transmission;
  3. How you’re handling errors, retries, and communication failures.

Even something as “technical” as how you format and transmit data can become a regulatory concern. So make sure your documentation covers it from day one.

📌 Check the FDA regulations and EU MDR regulations of Wireless Medical Devices for more details.

Interoperability Standards

Absolutely, you want your BLE-enabled app to fit into clinical ecosystems. So, it needs to play well with existing systems like EHRs or cloud platforms. Hence, you need to comply with these standards:

  • ISO/IEEE 11073: It defines how medical devices communicate with external systems. This standard is often used for vital signs monitoring.
  • HL7 FHIR: This standard helps structure electronic health data. In apps with Bluetooth-enabled medical devices, FHIR regulates data sync between mobile apps, cloud backends, and hospital systems.

Remember: If your app stores, transmits, or visualizes medical data over BLE, it’s not just a tech project. It’s a regulated medical product. Your compliance journey starts with smart architectural decisions.

⚕️ Types of Bluetooth Medical Devices

Now, let’s explore the 4 key categories of Bluetooth medical devices with real-world examples and development tips.

Clinical-Grade Wearables

While devices like Fitbit or WHOOP use Bluetooth Low Energy (BLE) to sync data like sleep and activity, they're consumer-focused. Great for wellness, but not built for clinical use.

Now compare that to a wearable Zio ECG monitor by iRhythm. It’s a FDA-cleared device designed for clinical-grade cardiac monitoring. It continuously records heart rhythms for up to 14 days, storing high-resolution ECG data. The ECG monitor transfers critical segments via BLE to a mobile app used by both patients and their doctors.

What differs Bluetooth medical monitoring devices from consumer wearables?

  1. More reliable BLE connectivity, even in interference-heavy environments like hospitals.
  2. GDPR and HIPAA-compliant data encryption from device to app to cloud.
  3. Cloud-based dashboards for providers. They cover more complex data analytics compared to pretty graphs in fitness tracking apps.
  4. Ultra-low power consumption. It’s a critical feature for medical devices that run for days or weeks without charging.

Need a tech partner who understands both Bluetooth and healthtech?

Contact Us

Remote Patient Monitoring (RPM) Devices

RPM is one of the fastest-growing types of connected health devices. They can transmit health vitals of patients directly to mobile apps, often without Wi-Fi.

Real-world examples:

  • Masimo MightySat is a Bluetooth-enabled pulse oximeter trusted by clinicians and athletes. It connects to the app over BLE to display SpO₂, pulse rate, and perfusion index in real time.
  • The iHealth Track Blood Pressure Monitor is an FDA-cleared device that uses BLE to sync readings with iOS/Android apps and generate shareable reports for doctors.
  • The Dexcom G7 is a continuous glucose monitor (CGM) that streams real-time glucose levels via BLE to smartphones or tablets. It’s a game-changer for people managing diabetes. Sadly, diabetes is a widespread chronic disease. Over 450 million people around the world suffer from this medical condition.

💡 What you should keep in mind when developing the app for Bluetooth medical devices:

  1. Ensure BLE reconnection logic, especially for long-term monitoring devices.
  2. Always alert users to failed data syncs and guide them how to solve this issue.
  3. Add offline-first functionality. Many RPM users live in areas with limited internet.

Implantable & In-Home Medical Systems

Even high-acuity medical systems (bedside terminals or wired connections) are getting a Bluetooth upgrade.

Real-world examples

  • Omnipod Dash is a Bluetooth-enabled insulin pump that lets users manage insulin delivery via a dedicated controller or app. BLE ensures real-time monitoring for patients and doctors.
  • Butterfly iQ+ Ultrasound is a pocket-sized ultrasound scanner that uses both BLE and Wi-Fi. The mobile app connects to the cloud, giving clinicians access to diagnostic imaging tools.

Tips for Bluetooth medical device developer from our healthcare app development company:

  1. BLE devices must have robust encryption and authentication.
  2. Many devices use hybrid protocols (BLE + Wi-Fi). So, you should use the mobile app with smooth switching and data flow management.
  3. You’ll need detailed documentation on wireless stability and security for regulatory submissions.

Telehealth & Rehabilitation Integrations

Bluetooth technology is also changing remote rehabilitation and virtual care. The healthtech apps help doctors monitor patients’ recovery exercises, pain levels, and mobility post-discharge.

Real-word examples

  • Compex Fit 5.0 uses BLE to connect muscle stimulators with mobile apps that guide and track rehabilitation sessions. Patients get real-time feedback; clinicians – remote visibility.
  • Kaia Health is a digital rehabilitation platform for musculoskeletal disorders. Their app uses BLE-enabled motion sensors to verify if users perform exercises correctly, making physical therapy more precise and personalized.

In telehealth settings, Bluetooth-enabled medical devices can stream vital signs during or around video calls. It’s a major win for virtual care workflows that still need “physical” context.

Our development tips for telehealth BLE integrations:

  1. BLE should work flawlessly across device models and OS versions.
  2. Sync timing should have minimal delays, especially if your app transfers data during live consultations.
  3. Want smooth EHR integration? Make your device and app FHIR-compliant from the start.

There are more successful real-world use cases of BLE-enabled devices in the healthcare industry. If you want to become one of them, you should think about compliance, reliability, and context-specific UX of your app. If to speak about Stormotion, it’s one of the parts of the Discovery Phase for our clients.

📈 Benefits of Bluetooth-Enabled Medical Devices

It’s obvious that BLE technology helps MedTech companies move faster to market, improve patient care for healthcare providers, and integrate seamlessly into digital health ecosystems. But let’s take a closer look at the other benefits of Bluetooth in medical devices for MedTech companies.

Business & Clinical Value

Time-to-market matters when you’re waiting for regulatory approvals or responding to investor expectations. This is where BLE gives you a head start:

  1. Standardized protocols like GATT and Bluetooth SIG health Device Profiles (heart rate, glucose, oximetry, etc.) reduce BLE app development time. Instead of reinventing the wheel, engineers can integrate these protocols into the app, saving your budget and speeding time-to-market.
  2. BLE chipsets are affordable and low-power, making them ideal for compact, battery-efficient devices like wearables and RPM tools.
  3. Your Tech Partner can reuse app infrastructure across product lines, rather than rebuilding everything for each device.

Real-world example:

The iHealth Labs ecosystem scaled quickly by integrating BLE infrastructure and reusing its app backend for new devices. Its product line includes various devices, from thermometers to blood pressure monitors, and all of them are FDA-compliant.

For clinical environments, Bluetooth for wireless medical devices also removes the need for dedicated wired setups or local hubs. It leads to cutting time and cost for deployment, maintenance, and the 24/7 support department.

Patient Engagement & Compliance

Device success depends not just on tech, but on how easy it is to use. It’s especially true for patients managing chronic conditions at home. BLE helps make connected care nearly invisible to the user:

  1. Fast setup. Users can connect BLE devices to an app in seconds via “Just Works” or Passkey pairing models. The simple onboarding process ensures patients can complete the setup by themselves without calling you or exploring the app settings.
  2. Passive data synchronization. Once paired, Bluetooth for wireless medical devices transmits data quietly in the background. Patients don’t need to do anything. Their blood pressure, glucose, or ECG data flows passively to the app or doctor dashboard.
  3. Proactive notifications. Apps can send real-time medication reminders (for example, “Time to take your medication”) or alerts for missed readings based on BLE data flow. Such care helps patients feel seen and supported.

Real-world example:

The Dexcom G7 uses BLE to send glucose readings to its app, which then triggers predictive alerts before levels drop or rise. This creates a continuous observation of patients’ health that improves diabetes management and reduces emergency interventions.

Integration with Digital Health Infrastructure

Bluetooth devices are now compatible with a broad digital health infrastructure.

  1. FHIR compatibility ensures BLE-transmitted vitals are formatted for easy integration with EHR or hospital dashboards.
  2. Bluetooth medical devices enable asynchronous care loops. They sync real-time data with a cloud system via an app. Then, the system can adjust treatments or schedule a follow-up.
  3. BLE’s low energy use and local-first mode don’t need as stable Wi-Fi connection. It’s a plus for patients who live in rural areas or those who live alone.

Real-world example:

The Withings BPM Core collects blood pressure and ECG data over BLE, uploads it via Wi-Fi or cellular to the Health Mate app, and then syncs it to EHRs using FHIR. The result? Physicians get data-based clinical insights, not just raw metrics.

In other words, BLE speeds up app development, saves costs, keeps patients engaged, and integrates with digital health infrastructure.

🚧 Challenges of Using Bluetooth for Medical Devices

Now, let’s take a look at challenges from the point of view of our Bluetooth medical device developer of mobile apps, Sergei Shemshur.

Limited Performance for Large Datasets

The main advantage of BLE is the "LE" part, low energy consumption. This is achieved by transmitting data infrequently. As a result, BLE offers limited data throughput, with a maximum speed of around 250 kbps, which makes it unsuitable for devices that need to transfer large amounts of data with low latency.

Additionally, since the maximum size of a BLE packet is 251 bytes, transmitting a large dataset requires a lot of packets. If you’re using React Native, this could negatively impact app performance, as a significant amount of time will be spent processing incoming packets.

To improve the situation, you can:

  1. Transfer packet processing to a native module.
  2. Implement data compression on the device side and decompress it in the app.
  3. Switch to Classic Bluetooth, which has higher throughput limits. But this leads to losing the low-energy benefits of BLE technology.

Security Issues

When a person constantly carries a BLE device that transmits data, intruders can track their location. Most Bluetooth medical monitoring devices still use static MAC addresses. In some cases, they could even intercept the transmitted data.

To mitigate these risks, it's important to:

  1. Use LE Secure Connections.
  2. Implement an additional layer of AES/GCM encryption at the application level.
  3. Use private MAC addresses, which periodically change to make tracking harder. Although these are only supported on peripheral devices in recent Android versions.

Connection Reliability

The 2.4 GHz band is extremely crowded today. It’s used by Wi-Fi, other Bluetooth devices, and even microwave ovens. On top of that, the human body consists of 60% water, and water absorbs radiation in this range. As a result, the connection might break if the device and the smartphone are on opposite sides of the body.

To improve the connection reliability of Bluetooth for medical devices, you can frequently check the connection status and reconnect automatically if it's lost.

Native modules can also help with this issue, allowing you to perform checks and reconnections more efficiently without the overhead of bridging data between Native code and React Native.

Background Limitations

Every new version of iOS and Android introduces stricter limitations on background activity. This means that when your React Native app is running in the background, some events might be missed because the JavaScript thread is suspended.

Native modules come to the help again:

  1. On iOS, you can maintain BLE connections and process data in the background. When the user opens the application, React Native app architecture will receive ready-made, processed data.
  2. For Bluetooth Low Energy Android, you can use foreground services to achieve the same result.

These challenges can be discouraging. But you can find a Tech Partner that knows how to overcome them and can help you build the companion app for Bluetooth medical devices.

Want to avoid Bluetooth limitations? We know how to solve these challenges.

Let’s talk!

🗂️ Stormotion Experience of Using Bluetooth for Medical Devices

Our team has experience integrating a Bluetooth-enabled wearable device into a STEPR fitness training system. This heart rate strep is worn by the user and communicates with the trainer's terminal via the Bluetooth protocol.

The device provides real-time heart rate data, and in more advanced versions of the protocol, it also transmits information such as calories burned and RR (the RP interval represents the time between two consecutive R waves in an Electrocardiogram (ECG) waveform) intervals.

Our React Native developer, Yevhenii Burkovskyi, will share more technical details about our experience with Bluetooth for medical devices.

According to official Bluetooth SIG documentation, heart rate monitors use the Heart Rate Service (UUID: 0x180D) and the Heart Rate Measurement Characteristic (UUID: 0x2A37).

The Heart Rate Measurement Characteristic contains time-sensitive data. As such, it is classified as a time-critical characteristic.

Bit

Meaning

0

Heart Rate Value Format (0 = UINT8, 1 = UINT16)

1

Sensor Contact Status present

2

Sensor Contact detected

3

Energy Expended present

4

RR-Interval present

5-7

Reserved (must be 0)

Here is how you can integrate a BLE-enabled heart rate monitor with the fitness machine or a companion mobile app.

1. Install and link

2. Set up the BLE manager

3. Scan, Connect, and Set Notification

As you see, Stormotion developers know how to integrate Bluetooth devices into the app and ensure its stable work and exceptional performance.

💡 Takeaways

To sum up, Bluetooth in medical devices, especially BLE, ensures faster go-to-market timelines, seamless mobile integration, and compliant, patient-centered healthcare experiences.

  • BLE fits clinical use cases. BLE offers the ideal balance of low power consumption, satisfactory data latency, and native mobile support. It’s the best choice for battery-powered smart medical devices for home and hospital environments.
  • Standard protocols reduce development time. With BLE protocols like GATT and predefined health data documentation, your team builds on proven, interoperable foundations instead of starting from scratch.
  • Compliance starts with architecture. You need to build the companion app for BLE-enabled medical devices with FDA, HIPAA, GDPR, and EU MDR requirements in mind right from the start.
  • Seamless mobile syncing improves performance. BLE technology ensures passive data syncing, real-time alerts, and frictionless pairing. You can increase patient engagement, reduce onboarding barriers, and ensure real-time vitals monitoring.
  • BLE + FHIR bridges the data gap. When implemented correctly, Bluetooth connects patient-facing devices with cloud-based EHRs. That means smarter clinical decisions, fewer manual entries, and scalable care models.

Looking to integrate Bluetooth medical devices into your app? Let’s talk about how Stormotion can help you build a compliant, mobile-first experience that syncs across platforms and meets the expectations of both regulators and users.

How can we help you?

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Stormotion client Alexander Wolff, CPO from [object Object]

When I was working with Stormotion, I forgot they were an external agency. They put such effort into my product it might as well have been their own. I’ve never worked with such a client-focused company before.

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Questions you may have

Take a look at how we solve challenges to meet project requirements

What medical devices use Bluetooth?

Bluetooth is used in all kinds of medical devices, from wearable sensors to in-clinic equipment, as long as there’s a short-range, real-time data exchange with a mobile app. BLE ensures a fast and secure connection for tracking vitals, monitoring rehabilitation progress, or supporting patient–provider communication.

What are future trends in Bluetooth medical devices?

Key Bluetooth medical devices trends include greater focus on interoperability, integration with preventive care platforms, and more advanced mobile features like over-the-air firmware updates and real-time data syncing for remote patient monitoring.

Are Bluetooth medical devices secure and compliant with privacy regulations?

Yes, when developed properly. BLE apps and devices can meet HIPAA, FDA, or EU MDR standards by implementing data encryption, secure pairing, and storage/transmission safeguards within both firmware and mobile app layers.

How do Bluetooth medical devices compare to cellular-enabled devices?

Bluetooth is ideal for short-range, app-driven use cases due to its low power consumption and real-time sync capabilities. Cellular is better for standalone devices in remote areas or when constant connectivity is required without relying on a mobile app.

How do you ensure stable and secure Bluetooth connectivity in clinical environments?

We implement robust connection protocols, advanced encryption, and thorough testing in medical settings. So, your devices maintain reliable and secure communication even in challenging environments.

How do you manage firmware updates and maintain compatibility with Bluetooth medical devices over time?

We design and implement seamless OTA (over-the-air) update processes and maintain strict version control to ensure your app and Bluetooth medical monitoring devices stay compatible and secure throughout their lifecycle.

What experience do you have with apps used by both healthcare professionals and patients?

We build health tech solutions for both physicians and patients with intuitive interfaces and reliable Bluetooth integrations that work seamlessly for both sides. You can read more about our Caspar Health and LifeBonus cases on the Portfolio page.

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