The 90-minute discussion explored the practical hurdles of moving new medical technologies from initial concept to commercial reality. Participants debated how data interoperability is dictating product development cycles and assessed the specific challenges facing the Utah life sciences sector. For Co-Diagnostics, the event arrives at a critical juncture as the company navigates the regulatory pathway for its latest diagnostic tools.
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Co-Diagnostics Joins Industry Roundtable on Medical Innovation
Amid a push to bring point-of-care molecular diagnostics to the U.S. market, Co-Diagnostics Chief Commercialization Officer Seth Egan joined industry leaders in Salt Lake City on August 13. The roundtable, hosted by Maschoff Brennen, focused on the shifting landscape of medical device regulation and the role of artificial intelligence.
Currently, the firm is awaiting FDA clearance for its Co-Dx PCR Flu A/B & RSV multiplex test, designed for use on the Co-Dx PCR Pro instrument. While the company is actively preparing for a potential U.S. launch, the entire PCR platform—including the PCR Home system and associated mobile applications—remains under regulatory review. Development of this technology began during the pandemic, and the company is now balancing domestic FDA submissions with broader efforts to secure international authorizations for its molecular testing suite.
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