VUNO's cardiac arrest prediction artificial intelligence (AI) medical device, VUNO Med-DeepCARS, did not receive final clearance in the U.S. Food and Drug Administration's (FDA) premarket notification review known as 510(k).
According to the industry on the 7th, VUNO said on its website that on the 30th of last month (local time) it was notified by the FDA that its 510(k) application for VUNO Med-DeepCARS received a "not substantially equivalent (NSE)" determination.
An NSE is a decision the FDA issues when it determines a new medical device has not sufficiently demonstrated equivalence to an already cleared product in terms of performance and safety. The 510(k) is one of the U.S. medical device approval pathways that evaluates safety and performance by comparing a device to a predicate product.
VUNO, however, explained that "this decision does not deny DeepCARS's core technology or clinical value," adding, "We understand it as a request for supplemental materials to more clearly demonstrate equivalence to the predicate product."
VUNO applied for 510(k) clearance for DeepCARS in early 2023. In June of the same year, it became the first domestic medical AI corporations to receive FDA Breakthrough Device designation, and the possibility of approval as early as 2024 was mentioned.
However, the FDA requested additional supporting materials, prolonging the review, and it recently received a final NSE determination.
The company plans to resubmit for FDA clearance after supplementing its clinical and performance data to meet U.S. standards.
VUNO CEO Lee Ye-ha said, "We feel a heavy responsibility for not meeting the high standards required by the U.S. regulator in this review," adding, "We will organize the clinical data and promptly reapply for clearance."