Nano-X AI Software HealthFLD Receives FDA 510(k) Clearance
Ticker: NNOX · Form: 6-K · Filed: Feb 13, 2024 · CIK: 1795251
Sentiment: bullish
Topics: regulatory-approval, AI, medical-device, product-launch
Related Tickers: NNOX
TL;DR
NANO-X IMAGING's AI subsidiary, Nanox AI, just got FDA clearance for its HealthFLD software, a major win for market entry!
AI Summary
On February 13, 2024, Nano-X Imaging Ltd. announced that its deep-learning medical imaging analytics subsidiary, Nanox AI Ltd., received 510(k) clearance from the U.S. Food and Drug Administration (FDA). This clearance is for its artificial intelligence (AI) software, HealthFLD. The approval marks a significant regulatory milestone for the company's AI-driven medical imaging product.
Why It Matters
FDA 510(k) clearance allows Nanox AI's HealthFLD software to be marketed and sold in the U.S., opening a crucial market for its AI-driven medical imaging analytics and potentially accelerating its commercialization efforts.
Risk Assessment
Risk Level: low — FDA clearance reduces regulatory risk and validates the product, generally viewed as positive news for a medical technology company.
Key Players & Entities
- Nano-X Imaging Ltd. (company) — registrant company
- Nanox AI Ltd. (company) — subsidiary receiving FDA clearance
- U.S. Food and Drug Administration (company) — regulatory body granting clearance
- HealthFLD (product) — AI software receiving 510(k) clearance
FAQ
What is the name of the company that filed this 6-K report?
The company that filed this 6-K report is NANO-X IMAGING LTD.
Which subsidiary of Nano-X Imaging Ltd. received FDA clearance?
The deep-learning medical imaging analytics subsidiary, Nanox AI Ltd., received the FDA clearance.
What is the name of the AI software that received 510(k) clearance?
The AI software that received 510(k) clearance is HealthFLD.
When was the FDA 510(k) clearance announced?
The FDA 510(k) clearance was announced on February 13, 2024.
What type of clearance did HealthFLD receive from the FDA?
HealthFLD received 510(k) clearance from the U.S. Food and Drug Administration (FDA).
Filing Stats: 226 words · 1 min read · ~1 pages · Grade level 9.6 · Accepted 2024-02-13 08:10:15
Filing Documents
- ea193560-6k_nanox.htm (6-K) — 12KB
- ea193560ex99-1_nanox.htm (EX-99.1) — 23KB
- 0001213900-24-012870.txt ( ) — 37KB
SIGNATURES
SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized. NANO-X IMAGING LTD . By: /s/ Ran Daniel Name: Ran Daniel Title: Chief Financial Officer Date: February 13, 2024 - 2 -