Dive Brief:
- The Food and Drug Administration gave 510(k) clearance to iRhythm Technologies’ second of two submissions for its Zio AT wearable cardiac monitoring system, moving the company a step closer to resolving a warning letter over problems found at a manufacturing facility. The clearance covers design modifications and labeling updates.
- The update, shared Wednesday during iRhythm’s earnings call, comes a week after the company gained a separate 510(k) clearance required for design modifications to the device, which remains on the market.
- CEO Quentin Blackford also told investors the company has decided to delay its FDA submission for the next-generation Zio MCT device until the third quarter of 2025, with a commercial launch expected in 2026.
Dive Insight:
The FDA issued a warning letter to iRhythm in 2023 after a facility inspection revealed issues that included failing to seek clearance before making changes to the Zio system and marketing it for a new, high-risk patient population. The Zio AT wireless patch monitor continuously records ECG data for up to 14 days.
On this week’s earnings call, Blackford said the company is extending its remediation efforts beyond the focus of the warning letter and additional FDA observations in July to exceed the agency’s expectations.
“We are rebuilding our entire quality management system, touching every aspect of it, including areas that have not been part of the FDA's recent inspections with the intent of making our quality system truly best in class,” Blackford said.
As a result of investments in its regulatory and quality functions, staffing in those operations has increased from 20 people two years ago to more than 100 employees. The company has hired a new leader for quality management and is working with a consulting firm to conduct internal audits of the quality system, the CEO said.
Blackford added that the company is taking time to ensure the thoroughness of the submission for its next-generation system.
“This approach will result in our voluntary efforts to perform additional testing, and documentation ahead of time in anticipation of questions that the agency may ask and demonstrate to the FDA the rigor with which we plan to approach product submissions in the future,” Blackford said.
The company reported an 18% increase year over year in third-quarter revenue, to $147.5 million. iRhythm also reported a net loss of $46.2 million in the quarter, compared with a loss of $27.1 million in the year-ago period.
William Blair analyst Margaret Kaczor Andrew said in a note to investors Thursday that while the filing delay is disappointing, it can help the company focus on integrating certified cardiographic technicians into its regulatory processes.
