Nano-X Imaging's Drug in the FDA Approval Process
This section highlights FDA-related milestones and regulatory updates for drugs developed by Nano-X Imaging (NNOX).
Over the past two years, Nano-X Imaging has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Nanox.ARC. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Nanox.ARC FDA Regulatory Timeline and Events
Nanox.ARC is a drug developed by Nano-X Imaging for the following indication: Digital x-ray technology.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Nanox.ARC
- Announced Date:
- February 3, 2026
- Indication:
- Digital x-ray technology
Announcement
NANO-X IMAGING LTD announced that the United States Food and Drug Administration (FDA) has granted 510(k) clearance for TAP2D, a new cloud enabled image enhancement capability for the Nanox.
AI Summary
Nanox Imaging Ltd announced that the U.S. Food and Drug Administration has granted 510(k) clearance for TAP2D, a cloud-enabled image enhancement for the Nanox.ARC tomosynthesis system. This clearance enables the next phase of development aimed ultimately at removing the adjunct use in the U.S.
TAP2D generates a 2D image directly from a tomosynthesis scan, giving radiologists both 3D and 2D views from a single scan without exposing the patient to additional radiation. That capability can streamline exams by avoiding separate 2D exposures and supporting more efficient interpretation.
The Nanox.ARC systems can receive software upgrades and new features like TAP2D remotely after regulatory clearances. Nanox plans to make the newly cleared enhancement available to existing installations as part of its ongoing rollout of imaging improvements.
Nanox says this aligns with its goal of expanding access to medical imaging by combining affordable hardware, cloud software, AI tools, and remote radiology to support earlier detection and more efficient care.
Read Announcement- Drug:
- Nanox.ARC
- Announced Date:
- November 13, 2025
- Indication:
- Digital x-ray technology
Announcement
NANO-X IMAGING announced that it will showcase its Nanox.ARC X multi-source digital tomosynthesis system and highlight development of new solutions for its AI portfolio at the Radiological Society of North America (RSNA) 2025 Annual Meeting, being held November 30 - December 4, 2025 in Chicago, IL.
AI Summary
Nano-X Imaging said it will showcase its Nanox.ARC X multi-source digital tomosynthesis system and highlight new AI solutions at the RSNA 2025 Annual Meeting in Chicago. The Nanox.ARC X is an AI-ready tomosynthesis scanner designed to bring advanced 3D imaging into more care settings. At the show the company will demonstrate its end-to-end imaging solution, which pairs the scanner with AI software, cloud services, and teleradiology tools.
Live demonstrations of Nanox.ARC X will run every 30 minutes at Booth #3914 (South Hall Level 3). Nanox will present an Innovation Theater talk on Dec. 2 at 11:00 am about a pulmonary nodule AI solution planned as a future Nanox.ARC X component. A poster on digital tomosynthesis in the musculoskeletal system will be on display, and Dr. Lawrence Tanenbaum will host a cocktail event on Dec. 1 at 5:30 pm.
Nanox also plans to unveil two standalone AI tools for aortic valve calcification measurement and body composition analysis. Company representatives will be available throughout RSNA for demos, clinical discussions, and partnership meetings.
Read Announcement- Drug:
- Nanox.ARC
- Announced Date:
- April 17, 2025
- Indication:
- Digital x-ray technology
Announcement
NANO-X IMAGING announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the Nanox.ARC X, its new multi-source digital tomosynthesis system.
AI Summary
Nano-X Imaging has received FDA 510(k) clearance for its new multi-source digital tomosynthesis system called Nanox.ARC X. This clearance, granted in less than 30 days after submission, allows the system to produce tomographic images for various applications, including assessments of the musculoskeletal system, lungs, abdomen, and sinuses. The Nanox.ARC X uses advanced digital sources and tomosynthesis technology to create sliced three-dimensional views that improve image clarity and reduce the overlapping of structures seen in traditional 2D X-rays.
The system features a sleek, compact design with a simple plug-and-play installation process, making it ideal for healthcare facilities with space limitations. Its design also supports remote software upgrades, enabling future enhancements as new regulatory clearances are obtained. This FDA clearance marks a significant step forward in expanding access to advanced digital 3D imaging technologies.
Read Announcement- Drug:
- Nanox.ARC
- Announced Date:
- December 5, 2024
- Indication:
- Digital x-ray technology
Announcement
NANO-X IMAGING announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Nanox.ARC, a stationary X-ray system intended to produce tomographic images for general use including human musculoskeletal system, pulmonary, intra-abdominal, and paranasal sinus indications, adjunctive to conventional radiography, on adult patients.
AI Summary
NANO-X IMAGING has received 510(k) clearance from the FDA for its Nanox.ARC, a stationary X‑ray system that produces tomographic images for adult patients. The system is designed to offer advanced imaging for a range of applications, including the human musculoskeletal system, pulmonary, intra‑abdominal, and paranasal sinus areas. It uses a high‑voltage digital X‑ray tube and state‑of‑the‑art tomosynthesis technology with a cold cathode to generate clear, sliced three‑dimensional views of the body. This technology minimizes the overlap of internal structures common in traditional 2D X‑rays, potentially speeding up diagnosis and improving patient care. With its new FDA clearance, the Nanox.ARC is now being deployed at several healthcare facilities in the U.S. as an accessible, cost‑effective solution that enhances conventional radiographic imaging practices.
Read Announcement
Nano-X Imaging FDA Events - Frequently Asked Questions
As of now, Nano-X Imaging (NNOX) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Nano-X Imaging (NNOX) has reported FDA regulatory activity for Nanox.ARC.
The most recent FDA-related event for Nano-X Imaging occurred on February 3, 2026, involving Nanox.ARC. The update was categorized as "FDA Clearance," with the company reporting: "NANO-X IMAGING LTD announced that the United States Food and Drug Administration (FDA) has granted 510(k) clearance for TAP2D, a new cloud enabled image enhancement capability for the Nanox."
Currently, Nano-X Imaging has one therapy (Nanox.ARC) targeting the following condition: Digital x-ray technology.
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FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
FDA progress for NASDAQ:NNOX last updated on 2/4/2026 by MarketBeat.com Staff. We continuously monitor for new FDA events and market data.
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