Inspira Technologies submits ART100 for regulatory approval
Ticker: IINNW · Form: 6-K · Filed: Mar 18, 2024 · CIK: 1837493
Sentiment: neutral
Topics: regulatory-submission, market-entry, medical-device
TL;DR
Inspira ART100 submitted for AMAR approval, targeting SEA & South America markets.
AI Summary
On March 18, 2024, Inspira Technologies Oxy B.H.N. Ltd. announced it has submitted its Inspira ART100 device to AMAR for regulatory approval. This submission is a key step towards entering the Southeast Asia and South American markets with their medical device.
Why It Matters
This regulatory submission is crucial for Inspira Technologies as it paves the way for market entry and potential revenue generation in new geographical regions.
Risk Assessment
Risk Level: medium — Regulatory approvals are inherently uncertain and can impact market entry timelines and success.
Key Players & Entities
- Inspira Technologies Oxy B.H.N. Ltd. (company) — Registrant
- Inspira ART100 (product) — Medical device submitted for approval
- AMAR (organization) — Regulatory body
- March 18, 2024 (date) — Date of announcement
FAQ
What is the specific product Inspira Technologies is submitting for regulatory approval?
Inspira Technologies is submitting its Inspira ART100 device for regulatory approval.
Which regulatory body is reviewing the Inspira ART100 submission?
The submission is made to AMAR.
What markets does Inspira Technologies aim to enter with this submission?
Inspira Technologies aims to enter the Southeast Asia and South American markets.
On what date was this announcement made?
The announcement was made on March 18, 2024.
What form type is this SEC filing?
This SEC filing is a Form 6-K.
Filing Stats: 312 words · 1 min read · ~1 pages · Grade level 8.9 · Accepted 2024-03-18 07:08:16
Filing Documents
- ea0201991-6k_inspira.htm (6-K) — 17KB
- ea020199101ex99-1_inspira.htm (EX-99.1) — 9KB
- 0001213900-24-023197.txt ( ) — 26KB
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: March 18, 2024 By: /s/ Dagi Ben-Noon Name: Dagi Ben-Noon Title: Chief Executive Officer 2