iRhythm Earns FDA Nod for Zio AT After Warning Letter

iRhythm Technologies has been granted U.S. Food and Drug Administration (FDA) 510(k) clearance for design changes made to its Zio AT device via a letter to file.
 
Zio AT came under scrutiny last May after the company was sent a warning letter concerning the mobile cardiac telemetry device. The letter accused iRhythm of violating Federal Food, Drug, and Cosmetic Act rules about labeling, medical device reporting, and quality systems. The company failed to report patient deaths in the required 30-day deadline and rather reported them the next year, according to the FDA.
 
iRhythm president and CEO Quentin Blackford said the clearance was a priority for its teams to show the company’s commitment to quality, compliance, and performance.
 
“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,” Blackford told the press. “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.”

More about the Zio AT system

iRhythm assured that the device remains available on the U.S. market.
 
The prescription-only mobile cardiac telemetry device is meant 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.
 
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. The ZEUS deep-learning algorithm analyzes cardiac events transmitted by the Zio AT device and gateway.
 
iRhythm said Zio AT services provide event transmission reports during wear and a comprehensive end-of-wear reportwith preliminary findings to the treating medical professional for final clinical decisions.