The CEO of Dexcom (Nasdaq:DXCM) said today that the company’s regulatory path for the next-generation G7 has been slightly delayed.
Speaking on the continuous glucose monitor (CGM) maker’s second-quarter earnings call, Dexcom Chair, President and CEO Kevin Sayer explained that the company has — based on feedback from the FDA — been tweaking the software of its next-generation G7, “slightly delaying” the expected timelines for FDA 510(k) clearance and the subsequent U.S. launch.
“We expect FDA clearance and a limited launch later this year and a large commercial launch in the U.S. in the first quarter of 2023,” Sayer said.
He added that, with preliminary discussions with payors progressing well, the company is set for a “big launch early next year.”
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