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IZOTROPIC CORP - IZOZF STOCK NEWS

Welcome to our dedicated news page for IZOTROPIC (Ticker: IZOZF), a resource for investors and traders seeking the latest updates and insights on IZOTROPIC.

Our selection of high-quality news articles is accompanied by an expert summary from Rhea-AI, detailing the impact and sentiment surrounding the news at the time of release, providing a deeper understanding of how each news could potentially affect IZOTROPIC's stock performance. The page also features a concise end-of-day stock performance summary, highlighting the actual market reaction to each news event. The list of tags makes it easy to classify and navigate through different types of news, whether you're interested in earnings reports, stock offerings, stock splits, clinical trials, fda approvals, dividends or buybacks.

Designed with both novice traders and seasoned investors in mind, our page aims to simplify the complex world of stock market news. By combining real-time updates, Rhea-AI's analytical insights, and historical stock performance data, we provide a holistic view of IZOTROPIC's position in the market.

News
Izotropic Receives Response From U.S. FDA
Rhea-AI Summary
Izotropic Corporation, a medical device company, announces that it has received a response from the U.S. FDA regarding its pre-submission seeking guidance on a Class II 510(k) pathway for its CT imaging system. The FDA's mammogram and ultrasound team has responded with additional questions, and Izotropic's management, regulatory, and engineering teams will promptly respond and report the outcomes. As of the announcement date, there has been no material change to the Company's regulatory plans and no definitive decision provided by the FDA.
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
12.75%
Tags
none
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News
Izotropic Provides Regulatory and Operational Updates
Rhea-AI Summary
Izotropic Corporation (CSE: IZO) (OTCQB: IZOZF) (FSE: 1R3) provides an update on its regulatory status with the U.S. Food and Drug Administration and operational activities, including FDA pre-submission meeting, ongoing correspondence, and business development discussions.
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
10.91%
Tags
none
-
News
Izotropic Completes Pre-Submission Meeting with U.S. FDA
Rhea-AI Summary
Izotropic Corporation, a medical device company, completed a pre-submission meeting with the U.S. FDA to discuss its application for market authorization. The meeting allowed Izotropic to clarify its regulatory strategy and the FDA appeared open to the company's new market clearance direction.
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
-7.14%
Tags
none
News
Izotropic Confirms FDA Pre-Submission Meeting Date
Rhea-AI Summary
Izotropic Corporation confirms pre-submission meeting with FDA for its CT imaging system, IzoView, on October 25, 2023.
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
-8.33%
Tags
none
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News
Izotropic Files Class II Pre-Submission with FDA & Releases Details on Predicate Devices
Rhea-AI Summary
Izotropic Corporation completes pre-submission application to FDA for market clearance of IzoView CT Imaging System as a Class II device. Plans to use pre-existing data for 510(k)-submission and aims for market clearance in the second half of 2024. Intends to secure collaborations with hospitals for generating clinical data. Switching to Class II pathway due to lower costs and shorter timeline. Selects CurveBeam HiRise and NeuroLogica OmniTom as predicate devices. Proceeding confidently with Class II 510(k) pathway.
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
6.44%
Tags
none
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News
Izotropic Modifies Market Approval Pathway & Strategy
Rhea-AI Summary
Izotropic Corporation modifies its FDA market approval pathway for IzoView, a breast imaging system, by deferring Class III device classification and pursuing Class II regulatory clearance. The modified strategy is expected to shorten the approval timeline, save $10+ million in investment, and provide broader intended use for clinicians.
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
4.6%
Tags
none
News
Izotropic CEO Resigns
Rhea-AI Summary
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
-6.94%
Tags
none
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IZOTROPIC CORP

OTC:IZOZF

IZOZF Rankings

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IZOZF Stock Data

5.62M
48.52M
10.11%
0.02%
Surgical and Medical Instrument Manufacturing
Manufacturing
Link
United States of America
Surrey