Inspira Technologies ART100 Gets FDA 510(k) Clearance
Ticker: IINNW · Form: 6-K · Filed: May 28, 2024 · CIK: 1837493
Sentiment: bullish
Topics: fda-clearance, medical-device, regulatory-approval
TL;DR
FDA greenlights Inspira's ART100 device for US market!
AI Summary
Inspira Technologies Oxy B.H.N. Ltd. announced on May 28, 2024, that its ART100 device has received FDA 510(k) clearance. This clearance allows the company to market its ART100 device in the United States. The company is a foreign private issuer filing a Form 6-K report.
Why It Matters
FDA clearance is a critical step for medical devices, enabling market entry and potential revenue generation in the United States.
Risk Assessment
Risk Level: medium — While FDA clearance is positive, the company's success will depend on market adoption, sales execution, and competition.
Key Players & Entities
- Inspira Technologies Oxy B.H.N. Ltd. (company) — Registrant
- ART100 (product) — Device receiving clearance
- FDA (company) — Regulatory body granting clearance
- May 28, 2024 (date) — Date of announcement
FAQ
What is the significance of the FDA 510(k) clearance for the ART100 device?
The FDA 510(k) clearance allows Inspira Technologies to market and sell its ART100 device in the United States.
When was the announcement regarding the FDA clearance made?
The announcement was made on May 28, 2024.
What type of filing is this report?
This is a Form 6-K report, which is a report of a foreign private issuer.
What is the primary business of Inspira Technologies OXY B.H.N. Ltd. based on its SIC code?
Based on its SIC code [3841], the company is in the Surgical & Medical Instruments & Apparatus industry.
Where is Inspira Technologies OXY B.H.N. Ltd. headquartered?
The company's principal executive office is located at 2 Ha-Tidhar St., Ra'anana, Israel.
Filing Stats: 286 words · 1 min read · ~1 pages · Grade level 8 · Accepted 2024-05-28 09:29:03
Filing Documents
- ea0206933-6k_inspira.htm (6-K) — 11KB
- ea020693301ex99-1_inspira.htm (EX-99.1) — 8KB
- 0001213900-24-046836.txt ( ) — 20KB
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. Inspira Technologies Oxy B.H.N. Ltd. Date: May 28, 2024 By: /s/ Dagi Ben-Noon Name: Dagi Ben-Noon Title: Chief Executive Officer 2