iRhythm Technologies Receives FDA 510(k) Clearance for Design Updates Previously Made to Its Zio® AT Device

Rhea-AI Summary

iRhythm Technologies (NASDAQ:IRTC) has received FDA 510(k) clearance for design updates previously made to its Zio AT device. The Zio AT, along with the Zio ECG Utilization Software (ZEUS), enables ambulatory Mobile Cardiac Telemetry (MCT) monitoring for non-critical care patients. This clearance is related to modifications and enhancements made via letter to file and demonstrates iRhythm's commitment to quality, compliance, and performance.

CEO Quentin Blackford stated that this is the first of two 510(k) clearances submitted at the beginning of the year, with the company expecting to hear about the second one soon. Both submissions are part of ongoing remediation efforts with the FDA. iRhythm remains committed to patient safety, physician trust in Zio AT's clinical performance, service quality, and regulatory compliance.

Positive

• FDA 510(k) clearance received for Zio AT device design updates
• Zio AT remains commercially available in the US market
• First of two 510(k) clearances obtained as part of FDA remediation efforts

Negative

• Ongoing remediation efforts with FDA indicate previous regulatory issues

Insights

Medical Device Regulatory Expert

The FDA's 510(k) clearance for iRhythm's Zio AT device design updates is a positive development for the company. This clearance validates previously made modifications, demonstrating iRhythm's commitment to regulatory compliance and product quality. It's important to note that:

• Zio AT remains commercially available in the U.S. market
• This is the first of two 510(k) submissions related to FDA remediation efforts
• The company expects a decision on the second 510(k) soon

For investors, this clearance reduces regulatory risk and reinforces iRhythm's position in the ambulatory cardiac monitoring market. However, the full impact will depend on the outcome of the second pending 510(k) submission.

Market Research Analyst

iRhythm's Zio AT device plays a important role in the company's product portfolio for ambulatory Mobile Cardiac Telemetry (MCT) monitoring. The FDA clearance strengthens iRhythm's market position:

• Enhances credibility with healthcare providers and patients
• Potentially expands market share in the $2 billion U.S. ambulatory cardiac monitoring market
• Supports iRhythm's competitive edge against rivals like BioTelemetry and Preventice Solutions

While this news is positive, investors should monitor the company's revenue growth, market share gains and the outcome of the second 510(k) submission to fully assess the long-term impact on iRhythm's financial performance.

Zio AT device, along with the Zio ECG Utilization Software (ZEUS) (K222389), enables the provision of ambulatory Mobile Cardiac Telemetry (MCT) monitoring service for non-critical care patients

SAN FRANCISCO, Oct. 21, 2024 (GLOBE NEWSWIRE) -- iRhythm Technologies, Inc. (NASDAQ:IRTC), a leading digital health care company focused on creating trusted solutions that detect, predict, and prevent disease, announced today that the U.S. Food and Drug Administration (FDA) has granted clearance for its 510(k) submission related to prior design changes made to the Zio AT device via letter to file. Zio AT remains commercially available on the market to ship to customers in the United States.

“This clearance is related to modifications and certain enhancements to our Zio AT device previously made via letter to file and has been a priority for our teams to demonstrate iRhythm’s commitment to quality, compliance and performance,” said Quentin Blackford, iRhythm President and Chief Executive Officer. “We are pleased to have received this first 510(k) clearance in line with the sequence of how we submitted the first of two 510(k)s at the beginning of this year, and we look forward to hearing about our second 510(k) in the near future. Both 510(k) submissions are related to our ongoing remediation efforts with the FDA, and we remain committed to patient safety, physician trust in Zio AT’s clinical performance, service quality, and regulatory compliance.”

About the Zio AT System

The Zio AT device is a prescription-only outpatient cardiac telemetry device, commonly referred to as a mobile cardiac telemetry device, which is used for the provision of our mobile cardiac telemetry (MCT) services. The Zio AT system consists of: the Zio AT patch, an ECG monitor that continuously records ECG data for up to 14 days; the wireless gateway that provides connectivity between the Zio AT patch and the Zio ECG Utilization Software (ZEUS) to transmit data during the wear period; and ZEUS, iRhythm’s deep-learning algorithm that analyzes cardiac events transmitted by the Zio AT device and gateway. The Zio AT services provide event transmission reports during wear and a comprehensive end-of-wear report^1-4 with preliminary findings to the treating medical professional for final clinical decisions. The Zio AT services are provided by iRhythm’s independent diagnostic testing facilities located in San Francisco, California, Deerfield, Illinois and Houston, Texas.

Zio Services’ Clinically Proven Performance

The value of the Zio service has been demonstrated in over 100 original scientific research manuscripts⁵. Zio AT’s patient-centered design enables high patient compliance and analyzable time with minimal noise or artifact^6-8, and real-world data shows an impressive 98% patient compliance⁹, in part thanks to Zio AT’s zero required patient manipulations. Furthermore, physicians agree with the Zio service's comprehensive end-of-wear report 99% of the time^10-11.

About iRhythm Technologies, Inc.
iRhythm is a leading digital health care company that creates trusted solutions that detect, predict, and prevent disease. Combining wearable biosensors and cloud-based data analytics with powerful proprietary algorithms, iRhythm distills data from millions of heartbeats into clinically actionable information. Through a relentless focus on patient care, iRhythm’s vision is to deliver better data, better insights, and better health for all. To learn more about iRhythm, including its portfolio of Zio products and services, please visit irhythmtech.com.

Zio AT Indications For Use

The Zio AT device is intended to capture and transmit symptomatic and asymptomatic cardiac events and record continuous electrocardiogram (ECG) data for long-term monitoring. It is indicated for use on patients 18 years or older who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, light-headedness, pre-syncope, syncope, fatigue, or anxiety. It is not intended for use on critical care patients.

Contraindications

• Do not use the Zio AT device for patients with symptomatic episodes where variations in cardiac performance could result in immediate danger to the patient or when real-time or in-patient monitoring should be prescribed.
• Do not use the Zio AT device for patients with known history of life-threatening arrhythmias.
• Do not use the Zio AT device in combination with external cardiac defibrillators or high frequency surgical equipment near strong magnetic fields or devices such as MRI.
• Do not use the Zio AT device on patients with a neuro-stimulator, as it may disrupt the quality of ECG data.
• Do not use the Zio AT device on patients who do not have the competency to wear the device for the prescribed monitoring period.
  

Investor Contact
Stephanie Zhadkevich
investors@irhythmtech.com

Media Contact
Kassandra Perry
irhythm@highwirepr.com

1. Zio AT Clinical Reference Manual. iRhythm Technologies, 2022.
2. Continuous, uninterrupted refers to the recording of ECG data. Zio AT Gateway transmissions may be impacted by a variety of factors. See Product Labeling for more information.
3. Zio AT is contraindicated for critical care patients.
4. Do not use Zio AT for patients with symptomatic episodes where variations in cardiac performance could result in immediate danger to the patient or when real-time or in-patient monitoring should be prescribed. Refer to the Zio AT labeling and Clinical Reference Manual for full contraindications.
5. Data on file. iRhythm Technologies, 2023.
6. Data on file. iRhythm Technologies, 2022-2023.
7. Zio XT Clinical Reference Manual. iRhythm Technologies, 2019.
8. Zio monitor Instructions for Use. iRhythm Technologies, 2023.
9. Zio AT Clinical Reference Manual. iRhythm Technologies, 2022.
10. Data on file. iRhythm Technologies, 2021-2022.
11. Based on a review of all online Zio XT, Zio monitor, and Zio AT end-of-wear reports. Data on file. iRhythm Technologies, 2023.
    

FAQ

What FDA clearance did iRhythm Technologies (IRTC) receive for its Zio AT device?

iRhythm Technologies received FDA 510(k) clearance for design updates previously made to its Zio AT device via letter to file.

What does the Zio AT device by iRhythm Technologies (IRTC) do?

The Zio AT device, along with the Zio ECG Utilization Software (ZEUS), enables ambulatory Mobile Cardiac Telemetry (MCT) monitoring for non-critical care patients.

How many 510(k) submissions did iRhythm Technologies (IRTC) make to the FDA in 2024?

iRhythm Technologies submitted two 510(k)s to the FDA at the beginning of 2024, with the first one now cleared and the second pending.

Why is iRhythm Technologies (IRTC) submitting 510(k)s for its Zio AT device?

The 510(k) submissions are part of iRhythm's ongoing remediation efforts with the FDA, demonstrating their commitment to quality, compliance, and performance.