Daniel Wilson has been named the new CFO of iRhythm Technologies, taking over from Brice Bobzien, who will step down due to personal reasons on August 31, as announced by the company. Bobzien, who joined iRhythm in August 2022 from Dexcom, expressed his decision on an earnings call, with CEO Quentin Blackford showing support and understanding for his situation. Blackford highlights the company’s solid succession planning, with Wilson being long considered as a potential successor.
Bobzien is set to continue his association with iRhythm in an advisory role until 2025. Wilson, who joined the company from Penumbra in 2019, has served in his most recent role since April 2023. His previous experience includes a significant stint at J.P. Morgan until 2016, where he notably advised iRhythm on its initial public offering.
The leadership transition announcement came alongside iRhythm’s financial results for the second quarter, where the company reported a 19.3% increase in revenue year-over-year, reaching $148 million. This growth was primarily driven by heightened demand for Zio cardiac monitoring services and a slight increase in average selling prices.
During the same earnings call, CEO Quentin Blackford addressed iRhythm’s ongoing response to a warning letter received from the Food and Drug Administration (FDA) in early 2023. The FDA’s concerns pertained to regulations for medical devices, focusing on medical device reporting requirements related to iRhythm’s Zio AT System and overall medical device quality system requirements. In response, iRhythm submitted two 510(k) applications concerning its Zio AT monitor, seeking to address issues highlighted by the FDA, including additional data on electromagnetic compatibility and human factors testing related to design changes.
Furthermore, Blackford revealed that the FDA had conducted inspections at iRhythm’s facilities in San Francisco and Orange County in July, which resulted in several observations, though specific details were not fully discussed during the call. Despite these findings, Blackford remains optimistic about the timeline for receiving 510(k) clearances, projecting a decision by September or October. He underscored an ongoing dialogue with the FDA to clarify regulatory expectations, particularly concerning the role of clinical technicians in relation to the product, a point on which iRhythm and the FDA currently hold differing views.
Blackford’s commentary also touched on potential misalignments in expectations between iRhythm and the FDA concerning complaint handling, reporting processes, and documentation procedures, emphasizing the company’s commitment to navigating these regulatory challenges while advancing their product offerings.
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