FDA Events for Nano-X Imaging (NNOX)
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:
- 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 April 17, 2025, involving Nanox.ARC. The update was categorized as "FDA Clearance," with the company reporting: "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."
Currently, Nano-X Imaging has one therapy (Nanox.ARC) targeting the following condition: Digital x-ray technology.
More FDA Event Resources from MarketBeat
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
This page (NASDAQ:NNOX) was last updated on 7/12/2025 by MarketBeat.com Staff
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