Page 67 - Plastics News July 2024

TECHNOLOGY NEWS

Element announces AI-powered plat-

form

According to insights from BTIG, a global financial
services firm, the average 510(k) premarket submis-
sion clearance takes approximately 162 days, nearly
Element Materials Technology (Element), a twice the FDA goal of 90 days. Delays in clearance
global provider of testing, inspection, and are commonly caused by the need for multiple sub-
certification (TIC) services, has announced mission turnarounds when missing or additional
the launch of Element RegNav (RegNav), information is required. In turn, manufacturers are
its first artificial intelligence (AI)-powered experiencing vast losses of time and money.
regulatory intelligence platform for medical
devices. To address these issues, RegNav has been co-devel-
oped with a specialised team of regulatory experts,
engineers, and data scientists. The expert pool is
comprised of ex-notified body regulatory profes-
sionals who have sought to ensure that the frame-
work of RegNav is comprehensive and accurate.

nitially launched to support FDA regulatory path- Jo Wetz, CEO of Element, said: “The end goal for
ways, RegNav will help bring medical innovations RegNav is simple, to help our customers bring life-
Ito market safely and more reliably for those in enhancing devices to market safely and more ef-
need. ficiently. Speaking to our existing medical device
customers we realise there is a real opportunity to
RegNav’s proprietary software combines AI with ex- alleviate confusion around medical device regula-
pert guidance to support medical device manufac- tion and standards, and further enhance our role as
turers in identifying the regulations, standards, re- a trusted partner in their compliance and certifica-
quirements, and testing needed to support the FDA tion journey.”
submission process. Currently, bringing a medical
device to market is a lengthy procedure with manu- Renae Leary, chief commercial officer at Element,
facturers facing a complex regulatory environment. said: “There is an incredible synergy between our

July 2024 PLASTICS NEWS 69