Nanox scores clearance for cloud-connected X-ray bed after years of FDA review
BIOMARKER
1. Nanox has received FDA clearance for its multi-source X-ray bed, Nanox.ARC, aimed at providing a compact imaging system for clinics and hospitals.
2. The Nanox.ARC can utilize up to five separate X-ray-emitting tubes simultaneously to create three-dimensional images of the body, similar to a CT scan.
3.The FDA's clearance covers the use of this stationary system in adults and its associated cloud-based computing infrastructure.
4. The FDA previously approved Nanox's single-source X-ray bed in early 2021.
5. Nanox plans to provide access to its multi-source imager through a pay-per-scan business model, with remote scan readings and analyses conducted via its teleradiology network.
6. The company aims to expand the availability of its systems to rural areas or regions lacking access to digital imaging and healthcare.
7. Nanox and its AI-focused subsidiary have recently received FDA approval for AI programs that help detect signs of osteoporosis.
8. Nanox's CEO, Erez Meltzer, stated that their innovative technology could increase access to medical imaging and shift healthcare towards proactive disease prevention and early detection.
9. The FDA approval process for the multi-source bed took longer than expected, with the company first submitting it in 2021.
10. Both the single-source and multi-source beds use Nanox's "cold cathode" emitter tube technology, which is marketed as a cost-effective alternative to traditional X-ray machines.