Cost Breakdown of FDA-Cleared Monitoring Systems

Remote patient monitoring (RPM) systems are transforming healthcare, but costs can vary widely depending on the device and insurance coverage. Here's a quick breakdown of the most popular FDA-cleared monitoring systems and their pricing:

• Dexcom G7: Premium continuous glucose monitor with advanced features like real-time readings every 5 minutes, customizable alerts, and Apple Watch integration. Costs around $5,000/year without insurance; most insured patients pay $0.

• FreeStyle Libre 3: Affordable glucose monitoring option with real-time updates every minute. Costs about $2,000/year out-of-pocket; many insured users pay $0–$35/month.

• iRhythm Zio Monitor: Wearable heart monitor for arrhythmia detection. Pricing depends on monitoring duration and insurance; financial assistance and installment plans are available.

• VitalConnect VitalPatch: Lightweight biosensor for cardiac and physiological monitoring. Widely covered by Medicare and private insurers, with monthly fees tied to clinical services.

Quick Comparison Table

Key Takeaway: Choose the system that fits your budget and health needs. For diabetes care, the FreeStyle Libre 3 is the most affordable, while the Dexcom G7 offers premium features. For heart monitoring, the Zio Monitor and VitalPatch provide flexible pricing and broad insurance coverage.

🩸2024 CGM (Continuous Glucose Monitor) Pricing

1. Dexcom G7 Monitoring System

The Dexcom G7 is a top-tier continuous glucose monitoring system, with its cost varying based on insurance coverage and payment methods. For those without insurance, the annual expense can be around $5,000 if using a smartphone as the primary display device. Adding a dedicated receiver increases the cost by $379.40.

Here’s a breakdown of out-of-pocket monthly costs:

These prices reflect the system’s premium nature, which is backed by its advanced features. The Dexcom G7 provides real-time glucose readings every 5 minutes and can connect directly to devices like the Apple Watch. Its compact design - 60% smaller than previous models - and a quick 30-minute warm-up time showcase its technical improvements.

"Dexcom G7 has given me so much freedom. I love the flexibility of wearing it on my arm or abdomen and the direct to watch feature is amazing, as I love being active and can keep an eye on my levels without needing to have my phone with me." - Jharna, Dexcom Warrior

For many, insurance greatly reduces the cost. 98% of users can access the G7 through pharmacy and durable medical equipment (DME) benefits. Medicare Part B also covers the G7 for qualifying patients who use insulin or require frequent blood sugar tests. Most insured patients pay $0, while Medicare beneficiaries typically cover 20% coinsurance of the allowed amount. For those without strong coverage, additional programs can help lower expenses.

Dexcom offers several cost-saving options:

• Pharmacy Savings Program: Get $210 off every 30-day supply of sensors.

• Receiver Discount: Receive $200 off the Dexcom G7 Receiver.

• Patient Assistance Program: Available for eligible U.S. residents who meet specific income requirements.

The Dexcom G7 also includes features like customizable alerts, including an "Urgent Low Soon" warning that provides up to a 20-minute heads-up for potential hypoglycemic events. Additionally, users can share their glucose data with up to 10 followers through the Dexcom Follow app, making it easier for healthcare providers and family members to stay informed.

2. FreeStyle Libre 3 System

The FreeStyle Libre 3 stands out as one of the most affordable FDA-approved continuous glucose monitoring (CGM) systems. If you're paying out-of-pocket, the total annual cost is around $2,000. This includes a one-time purchase of the reader for $174 and sensors priced at approximately $150 for a 28-day supply when using a GoodRx discount.

Here’s a quick look at the costs and coverage options:

One of the key features of the FreeStyle Libre 3 is its streamlined design, which eliminates the need for a separate transmitter. Abbott, the manufacturer, also offers several cost-saving programs. These include the MyFreeStyle Program (potentially offering a free sensor for eligible self-paying patients), Customer Care Vouchers (available when insurance copays exceed $75 for two sensors), and Medicare Coverage for those who qualify. These programs make it easier to manage costs while benefiting from advanced sensor technology.

The system provides real-time glucose readings every minute, which can be accessed directly on your smartphone. Its sensor is not only the smallest and thinnest available but also water-resistant (up to 3 feet for 30 minutes) and maintains a connection within a 33-foot range. With a lifespan of up to 14 days per sensor, the FreeStyle Libre 3 offers a practical balance of affordability and functionality, making it an appealing choice for continuous glucose monitoring.

Clinical studies have shown that patients with Type 2 diabetes using the system experienced an average reduction of 1.6% in their A1C levels. Medicare also provides coverage for eligible users. With its combination of affordability, convenience, and effectiveness, the FreeStyle Libre 3 is well-suited for long-term use.

3. iRhythm Zio Monitor

The iRhythm Zio Monitor combines FDA-cleared hardware with advanced analysis, offering two primary service options: Zio XT and Zio AT. Pricing depends on your insurance coverage and the length of monitoring.

Out-of-pocket costs can vary, but iRhythm provides several payment options to help manage expenses:

• Financial Assistance Program for eligible patients

• Self-Pay Pricing for those without insurance

• Monthly Installment Plans (interest-free for up to 12 months)

• Prompt Pay Program offering discounts for immediate payments

Clinical data shows the Zio Monitor detects atrial fibrillation 2.6 times more effectively than standard care methods. This high detection rate highlights its effectiveness in remote monitoring. Additionally, 91% of users find the device easy to use, and 90% say they would wear it again.

"iRhythm aims to provide the best clinical care to the patient, irrespective of their ability to pay, and we offer multiple payment options to ease the financial burden."

• iRhythm Technologies

Steps Before Receiving Your Monitor

1. Verify insurance coverage using the relevant CPT codes.

2. If your insurance is out-of-network, contact iRhythm for guidance.

3. Call the Patient Financial Navigator team at 1-888-693-2401 for cost details.

Billing includes the entire monitoring period, and you'll receive an Explanation of Benefits before the final bill - this ensures transparency, especially if coverage appeals are needed.

To date, iRhythm has analyzed data from about 8 million patients, amounting to over 1.5 billion hours of heartbeat data. With a 99% physician agreement rate on reports, the system delivers reliable results. Its high diagnostic accuracy and reduced need for retesting make it a cost-effective solution for both patients and healthcare providers. This pricing model aligns well with the approaches discussed earlier.

4. VitalConnect VitalPatch System

The VitalConnect VitalPatch System is an FDA-cleared, Class II wearable biosensor designed for remote monitoring. Below, we’ll break down its pricing details, insurance coverage, and cost-saving benefits.

Core Components and Pricing Structure

At the heart of the system is a lightweight, 13-gram disposable biosensor patch. It also includes the VitalCore processor, a proprietary ASIC, and low-energy Bluetooth connectivity for seamless operation.

Here’s a snapshot of typical costs based on Medicare reimbursement structures:

Insurance Coverage and Reimbursement

VitalConnect’s system is widely accepted by insurers, including Medicare/CMS, Medicaid across 42 states, and numerous private insurance providers.

"We are fully reimbursed and accredited through CMS and Medicare on our cardiac monitoring platform... We are reimbursed through the national code set by CMS for the Holter, extended Holter and MCT (mobile cardiac telemetry) platforms. On the hospital at home and general RPM, we are fully reimbursed under the hospital-at-home guidelines and the DRGs as well as the global codes established for monitoring physiological parameters." - Peter Van Haur, CEO of VitalConnect

Cost-Saving Features

The VitalPatch System significantly reduces acute care costs - by up to 67% during the 30 days following discharge. It’s designed for convenience, requiring no assembly or charging, and supports seven-day continuous wear. The system is capable of monitoring 21 cardiac arrhythmias.

While the system offers substantial savings, users should keep a few financial considerations in mind:

• Timely co-payments: Avoid late fees by paying co-pays on schedule.

• Return devices promptly: Ensure devices are returned to avoid extra charges.

• Data collection requirements: Collect data for at least 16 days within a 30-day period.

The monitoring center is staffed by nationally certified technicians and uses FDA-cleared AI from Cardiologs Technologies for ECG analysis. This ensures accurate arrhythmia detection and vital sign monitoring, all while integrating smoothly with electronic medical records.

"Our Extended Holter NOW solution benefits physicians through access to real-time and historic patient data, giving more insight into the condition of the patient." - Dr. Joseph Roberson, Chief Medical Officer for VitalConnect

These features, combined with its pricing and insurance coverage, position the VitalPatch System as a competitive option among FDA-cleared monitoring solutions.

Cost and Feature Comparison

This section provides a detailed look at FDA-cleared remote monitoring systems, focusing on their pricing structures and essential features.

Cost Analysis

Here’s a snapshot of the pricing for different systems as of May 2025:

These pricing differences highlight the unique offerings and affordability of each system, depending on the user's insurance coverage and discounts.

Value Proposition Analysis

FreeStyle Libre 3

• Recognized as the most budget-friendly option among CGM systems, with monthly costs ranging from $199 to $1,188 through Deliver My Meds.

• Availability confirmed through September 30, 2025.

Dexcom G7

• Offers significant savings through its Pharmacy Savings program, providing over $200 in monthly discounts and access to a wide coverage network.

Cost-Saving Opportunities

Using these systems can lead to long-term savings by reducing the need for frequent clinic visits, enabling earlier detection of health issues, and improving overall patient outcomes. These benefits align with the aim of advancing remote patient care while helping to lower healthcare expenses.

Feature Comparison Matrix

Beyond pricing, all systems share critical functional capabilities, such as real-time monitoring:

This comparison underscores the shared ability of these FDA-cleared devices to provide continuous and effective patient monitoring, ensuring high-quality care across various use cases.

Summary and Recommendations

Our analysis highlights that FDA-cleared monitoring systems deliver varying cost-benefit outcomes depending on specific healthcare needs. Below, we outline budget-friendly options, premium features, and key factors for choosing the right system.

Budget-Conscious Options

For those prioritizing affordability, the FreeStyle Libre 3 stands out. It offers a low-cost solution with continuous glucose readings updated every minute.

Premium Features Selection

The Dexcom G7 is a top-tier choice for users seeking advanced capabilities, including:

• Customizable glucose alerts for better control

• Seamless integration with insulin pumps

• A faster 30-minute warm-up time

• Improved accuracy for reliable readings

Cost-Effectiveness Analysis

Remote patient monitoring (RPM) systems continue to demonstrate considerable healthcare savings. A study published in the Journal of American Medicine Association found that RPM implementation led to:

• An 87% reduction in hospitalizations

• A 77% decrease in mortality rates

• $11,472 saved per patient compared to standard care

Technology Considerations

Technical features play a critical role in determining a system's overall value. Here's a comparison of Bluetooth and cellular-based devices:

These differences illustrate the trade-offs between initial costs and long-term convenience.

For healthcare providers, the financial potential of RPM systems is significant. A clinic enrolling 50 patients could generate around $72,000 annually based on current reimbursement rates.

Recommended Selection Criteria

When choosing a monitoring system, consider the following:

• Ensure ISO 9001:2000 and FDA 21 CFR Part 11 certifications

• Evaluate the ease of installation and maintenance

• Assess continuous monitoring capabilities

• Review data reporting and compilation features

• Confirm the availability of manufacturer support and training programs

The monitoring system market is evolving rapidly, with an expected growth rate of 18.6% CAGR from 2024 to 2030. This growth signals ongoing advancements in technology and the potential for more competitive pricing in the near future.

FAQs

How do insurance plans and cost-saving programs make FDA-cleared monitoring systems more affordable?

Insurance plans and discount programs are essential in making FDA-cleared monitoring systems more budget-friendly for patients. Health insurance companies often evaluate these devices based on their clinical effectiveness and the value they provide. If a device shows it can enhance patient outcomes, insurers are more likely to cover it, which can drastically cut down out-of-pocket costs.

On top of that, cost-saving initiatives like mail-order pharmacies or specialized provider networks can help reduce overall healthcare expenses. These programs not only make advanced monitoring systems easier to access but also encourage the adoption of modern technologies that aim to improve patient care.

How do the Dexcom G7 and FreeStyle Libre 3 glucose monitoring systems compare in features and cost?

The Dexcom G7 and FreeStyle Libre 3 are two widely used continuous glucose monitoring (CGM) systems, each with distinct features and pricing.

The Dexcom G7 stands out for its impressive accuracy, boasting a mean absolute relative difference (MARD) of about 8.4%. It delivers real-time glucose updates every minute and requires just a 30-minute warm-up period. The system integrates the sensor and transmitter into a single device, simplifying the setup. Each sensor lasts 10 days, with a pack of three priced at approximately $340, translating to an estimated annual cost of around $5,000 without insurance.

On the other hand, the FreeStyle Libre 3 offers a longer sensor lifespan of 14 days and is generally more budget-friendly. A 28-day supply costs roughly $150, making it a more economical choice. Like the Dexcom G7, it provides real-time glucose readings, but users must scan the sensor to access their data. Its MARD is slightly higher at 9.4%, indicating a bit less accuracy compared to the Dexcom G7.

In short, the Dexcom G7 caters to those seeking advanced features and top-tier accuracy, while the FreeStyle Libre 3 appeals to individuals looking for a more affordable option for basic glucose monitoring.

What heart monitoring features do the iRhythm Zio Monitor and VitalConnect VitalPatch offer, and are there financial assistance options available?

The iRhythm Zio Monitor provides continuous heart monitoring, making it easier to spot irregular heart rhythms over longer periods. It's covered by most major insurance plans, including Medicare. For patients without insurance or those dealing with financial difficulties, iRhythm offers a discounted self-pay option as well as an income-based financial assistance program for those who qualify.

The VitalConnect VitalPatch specializes in real-time monitoring of vital signs and arrhythmias, delivering data that can help manage heart health effectively. While it's also covered by many insurance providers, details about financial assistance aren't as clear. It's a good idea to contact your insurance provider directly for more information.

Both devices use advanced monitoring technology to promote better heart health and include options aimed at making them more accessible for patients who need them.