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Element Launches RegNav AI-Powered Platform

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Element Materials Technology has announced the launch of Element RegNav (RegNav), its first artificial intelligence (AI)-powered regulatory intelligence platform for medical devices. Initially launched to support FDA regulatory pathways, RegNav will help bring medical innovations to market safely and more reliably for those in need.

RegNav’s proprietary software combines AI with expert guidance to support medical device manufacturers in identifying the regulations, standards, requirements, and testing needed to support the FDA submission process. Currently, bringing a medical device to market is a lengthy procedure with manufacturers facing a complex regulatory environment.

According to insights from BTIG, a global financial services firm, the average 510(k) premarket submission clearance takes approximately 162 days, nearly twice the FDA goal of 90 days. Delays in clearance are commonly caused by the need for multiple submission turnarounds when missing or additional information is required. In turn, manufacturers are experiencing vast losses of time and money.

To address these issues, RegNav has been co-developed with a specialized team of leading regulatory experts, engineers, and data scientists. The expert pool is comprised of ex-notified body regulatory professionals who have sought to ensure that the framework of RegNav is comprehensive and accurate.

Source: Element Materials Technology

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