Name: Daniel Wilson
New title: CFO, iRhythm Technologies
Previous title: Executive vice president of corporate development and investor relations, iRhythm
Daniel Wilson will become CFO of iRhythm Technologies when Brice Bobzien steps down for personal reasons on Aug. 31, the company said Thursday.
Bobzien joined iRhythm from Dexcom to serve as CFO in August 2022. On an earnings call Thursday, iRhythm CEO Quentin Blackford expressed disappointment that Bobzien is leaving and provided a brief overview of the CFO’s decision to step down.
“I respect his decision as he deals with unfortunate personal matters at this time. Importantly, he’ll be nearby as we work through this transition to Dan,” Blackford said. “Succession planning is something that we spend a good amount of time with here at iRhythm, and Dan has long been seen as a potential successor to Brice.”
Bobzien will continue in an advisory capacity into 2025.
Wilson joined iRhythm from Penumbra in 2019 and took on his current role in April 2023. Until 2016, the incoming CFO worked at J.P. Morgan, where he advised iRhythm on its initial public offering.
iRhythm disclosed the leadership change alongside its financial results for the second quarter. Revenue increased 19.3% year over year to $148 million, fueled by demand for Zio cardiac monitoring services and a slight rise in the average selling price.
Warning letter update
Blackford used the quarterly earnings call to provide an update on iRhythm’s response to the warning letter the Food and Drug Administration sent in 2023. The FDA found “nonconformities to regulations for medical devices, including medical device reporting requirements, relating to the company’s Zio AT System and medical device quality system requirements.”
In January, iRhythm filed two 510(k) submissions related to its Zio AT monitor in response to the warning letter. Zio AT is a mobile cardiac monitor that patients use for up to 14 days, whereas Zio XT is a long-term monitor.
The FDA has asked for “data that included incremental electromagnetic compatibility or EMC testing, and human factors testing around design changes made to satisfy their request,” Blackford said. iRhythm plans to respond in the near term, the CEO said.
Blackford also revealed the FDA inspected iRhythm’s facilities in San Francisco and Orange County in July. The inspections concluded with “several 483 observations noted,” the CEO said, and iRhythm is in the early stages of evaluating the findings. Blackford said the inspection has not changed his thinking about the timing of the 510(k) clearances, adding that iRhythm is on track for a decision in September or October.
Asked by an analyst about the nature of the inspection observations, Blackford said “I think it’s clear that the FDA is trying to define, frankly, how to regulate this relatively new category.”
The fundamental issue is whether the clinical technicians are part of the product or not, the CEO added. iRhythm views them as separate items, while the FDA has a different perspective.
“When you start to think about those two things differently — meaning ourselves versus how the FDA may be looking at it — you start to land in different places, when it comes to complaint handling or reporting or process controls and how you document those controls or how you go about your statistical techniques,” said Blackford.