Quantib Secures FDA Clearance for AI Workflow Platform

Artificial intelligence (AI) solutions company Quantib secured 510(k) clearance from the U.S. Food & Drug Administration (FDA) this week for its AI workflow integration platform, Quantib AI Node.

Designed to help radiologists process CT and MRI scans faster, company officials said, the “plug-and-play” tool can assist with more rapid diagnosis, potentially leading to better outcomes.

“Quick, accurate diagnoses are the first crucial step towards better outcomes, yet most of the platforms radiologist are told to work with remain underutilized because of a complicated user experience,” said Arthur Post Uiterweer, Quantib’s chief executive officer.

Company leaders said they hope securing FDA clearance will enable the platform to alleviate some pressures caused by resources that are already stretched thin due to the COVID-19 pandemic. To bring its solution closer to radiologists state-side, the Netherlands-based company has opened a New-York based office.

So far, said one investigator who has tested Quantib’s AI platform, the tool’s performance has been effective.

“Our (pre-clinical) experience with the new Quantib AI Node is excellent,” said Wouter Veldhuis, M.D., Ph.D., a radiologist with the University Medical Center Utrecht. “It integrates seamlessly and already shows it can scale with increasing load and newly available algortihms. I really see this helping us improve patient care.”