US-based digital healthcare company iRhythm Technologies has received the US Food and Drug Administration (FDA) 510(k) approval for design changes to its Zio AT device.
The Zio AT device is a prescription-only outpatient cardiac telemetry device, commonly known as a mobile cardiac telemetry device, used for mobile cardiac telemetry (MCT) services.
The system contains the Zio AT patch, an ECG monitor that continuously records ECG data for up to 14 days, and the company’s Zio ECG Utilization Software (ZEUS).
It also includes a wireless gateway that provides connectivity between the Zio AT patch and ZEUS to transmit data during the wear period.
ZEUS is a deep-learning algorithm that analyses cardiac events transmitted by the Zio AT device and the wireless gateway.
iRhythm said that its Zio AT device will continue to be available to customers in the US.
iRhythm president and CEO Quentin Blackford said: “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.
“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.”
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 patients aged 18 years and above, with symptoms such as palpitations, shortness of breath, dizziness, light-headedness, pre-syncope, syncope, fatigue, or anxiety.
iRhythm provides the Zio AT services through its independent diagnostic testing facilities in San Francisco, California, Deerfield, Illinois and Houston, Texas.
Zio AT’s patient-centred design enables high patient compliance and analysable time with minimal noise, and real-world data shows an impressive 98% patient compliance.
