Nanox (NASDAQ: NNOX) has announced receiving FDA 510(k) clearance for TAP2D, a new cloud-enabled image enhancement capability for the Nanox.ARC and Nanox.ARC X digital tomosynthesis systems.
According to Nanox, the FDA-cleared enhancement capability provides radiologists with an additional, clear 2D view, generated from the digital tomosynthesis scan—enabling both 3D and 2D views from a single scan without exposing the patient to additional radiation.
Erez Meltzer, CEO and acting chairman of Nanox, commented, “We are pleased to receive FDA clearance for TAP2D. This clearance provides important regulatory insights as we work toward our goal of removing the adjunctive use in the U.S., which would allow the Nanox.ARC to serve as a standalone primary imaging solution as it already does in Europe under CE Mark certification. We remain focused on delivering innovations that elevate patient care and broaden access to high quality imaging around the world.”
