RE: IB Zero g16 Aug 2022 10:41
Well think the RNS has shattered that thought. Going to be a long haul on this one.
As reported on May 31, we submitted an FDA 510(k) application to the USFDA. IB Zero G™ is an automated processing pipeline that leverages patented technology (US Patent No. 11,100,621) to output enhanced post-contrast images using routinely acquired non-contrast images as input. This technology is targeted at the multibillion-dollar global MRI contrast media market offering cost, convenience, and alleviating safety and environmental concerns. The initial 510(k) application followed the Traditional 510(k) pathway. Under this pathway, the sponsoring company identifies a previously FDA cleared "predicate" device and uses the attributes of that predicate device to demonstrate "substantial equivalence" for the new device. The FDA has now determined that the patented artificial intelligence (AI) technology contained in IB Zero G is a novel, a "first in kind", such that no currently cleared device exists that can serve as a predicate to establish substantial equivalence.
In the response, the FDA provided several alternatives including a "de novo" application. The de novo pathway is specifically designed for novel medical devices intended as Class I and Class II (a risk-based classification) and allows the FDA to review new technologies more expeditiously such that patients can have access to safe and effective medical devices sooner. Prior to the establishment of the de novo pathway, novel technologies were automatically considered Class III (highest risk) and underwent a much more rigorous and longer market clearance pathway, called a Premarket Approval (PMA). We do not believe IB Zero G is appropriately considered a Class III device, so IB intends to take advantage of the de novo pathway and will be communicating with the FDA for further clarification and guidance in advance of the de novo submission.
The de novo pathway is simpler and is becoming more frequently used, driven in part by the rapid pace of technology, computing power, and AI algorithmic development.
Sign In
Follow the stocks
