Nanox Gains FDA Clearance for TAP2D in Digital Tomosynthesis Platforms

Nanox Imaging Ltd has achieved an important regulatory milestone with the recent FDA 510(k) clearance for TAP2D, a new cloud-enabled image enhancement feature for its Nanox.ARC and Nanox.ARC X systems. This development aims to enhance the diagnostic utility of their digital tomosynthesis platforms.

The TAP2D feature allows radiologists to generate a 2D image directly from a tomosynthesis scan, offering both 3D and 2D views without increasing the patient’s exposure to radiation. This capability is designed to streamline the workflow within clinical settings, adding function without complexity for medical staff.

Nanox’s systems are recognized for utilizing advanced 3D imaging to deliver diagnostic capabilities more cost-effectively and with less radiation compared to traditional imaging systems. This software, including the newly cleared TAP2D, can be remotely added to existing systems, contingent on further regulatory clearances.

Nanox CEO Erez Meltzer expressed satisfaction with the clearance, emphasizing that it furthers their goal of positioning the Nanox.ARC as a standalone imaging solution in the US, similar to its current status in Europe under CE Mark certification. The company remains dedicated to broadening access to high-quality imaging solutions worldwide.

Existing installations of Nanox systems will soon have access to the TAP2D enhancement as part of the company’s commitment to ongoing imaging improvements. This step is seen as part of Nanox's broader strategy to integrate its various technologies, including AI solutions and cloud-based platforms, to promote preventive health care through more accessible and efficient imaging services globally.