Inspira Announces 97.3% Accuracy Results for HYLA™ Blood Sensor, Advancing Toward FDA Submission for Clearance
Inspira Technologies Oxy B.H.N. Ltd. - Ordinary Shares (IINN)
Company Research
Source: GlobeNewswire
RA'ANANA, Israel, Sept. 11, 2025 (GLOBE NEWSWIRE) -- Inspira™ Technologies OXY B.H.N. Ltd. (NASDAQ: IINN) ("Inspira," “Inspira Technologies,” or the "Company"), a pioneer in innovative life-support and diagnostic technologies, today announced pivotal results for its HYLA blood sensor, achieving 97.35% accuracy in its latest performance testing phase that will support its upcoming U.S. Food and Drug Administration (“FDA”) submission. These results represent a significant advancement from the initial data obtained in a clinical study, as announced on March 4, 2025. The clinical study from March, conducted at a medical center ranked among the world’s leading hospitals, provided validation for HYLA’s performance, while these latest test results confirm the device's readiness for the regulatory pathway in the U.S. and Europe. Key features of the HYLA Blood Sensor include: High Accuracy: Achieves 97.35% accuracy relative to standard blood gas analyzers.Continuous Monitoring: Provides
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News
- Inspira Technologies Announces Strategic Leap in Lab Capabilities – Accelerating Next-Generation Diagnostics and Blood TechnologyGlobeNewswire
- Inspira Technologies OXY B.H.N. (NASDAQ:IINN) had its "sell (d-)" rating reaffirmed by analysts at <a style="font-weight:bold" href="https://weissratings.com/">Weiss Ratings</a>.MarketBeat
- Inspira Completes Clinical Study for HYLA™ Blood Sensor - Ahead of Regulatory SubmissionGlobeNewswire
- Inspira Technologies Nears Final Regulatory Clearance for the ART100 in the UAE, Accelerating Gulf Region ExpansionGlobeNewswire
- Inspira Technologies OXY B.H.N. (NASDAQ:IINN) was upgraded by analysts at <a style="font-weight:bold" href="https://www.wallstreetzen.com/newsletters/zen-ratings?ticker=IINN&utm_campaign=getratings&utm_medium=online&utm_source=MarketBeatMarketBeat
IINN
Sec Filings
- 12/3/25 - Form 6-K
- 11/25/25 - Form F-3/A
- 11/25/25 - Form 6-K
- IINN's page on the SEC website