Izotropic Confirms FDA Pre-Submission Meeting Date
Vancouver, British Columbia--(Newsfile Corp. - September 27, 2023) - Izotropic Corporation (CSE: IZO) (OTCQB: IZOZF) (FSE: 1R3) ("Izotropic" or the "Company"), a medical device company commercializing IzoView, a CT (computed tomography) imaging system, that produces images of anatomy for non-invasive tissue characterization with the first application in breast imaging, announced today it has confirmed a pre-submission meeting date with the U.S. Food and Drug Administration (FDA) scheduled for October 25, 2023.
Further to its news release on September 6, 2023, Izotropic completed a pre-submission application to the FDA to solidify its plans to pursue market clearance for IzoView as a Class II device through a 510(k) pre-market notification submission.
The purpose of the upcoming meeting is to discuss the application, obtain feedback, and confirm next steps. The meeting will take place in Rockville, Maryland, and will be attended by Izotropic's management, technical and engineering team members, and its FDA consultant, Matrix Medical Devices.
The Company will issue a news release in due course after the meeting to report on its progress.
ON BEHALF OF THE BOARD
Mr. Robert Thast, CEO
Toll Free: 1-833-IZOCORP ext.1
This document may contain statements that are "Forward-Looking Statements," which are based upon the current estimates, assumptions, projections, and expectations of the Company's management, business, and its knowledge of the relevant market and economic environment in which it operates. The Company has tried, where possible, to identify such information and statements by using words such as "anticipate," "believe," "envision," "estimate," "expect," "intend," "may," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," "contemplate" and other similar expressions and derivations thereof in connection with any discussion of future events, trends or prospects or future operating or financial performance, although not all forward-looking statements contain these identifying words.
These statements are not guarantees of performance and involve risks, including those related to capital requirements and uncertainties that are difficult to control or predict, and as such, they may cause future results of the Company's activity to differ significantly from the content and implications of such statements. Forward-Looking Statements are pertinent only as of the date on which they are made, and the Company undertakes no obligation to update or revise any Forward-Looking Statements to reflect new information or the occurrence of future events or circumstances unless otherwise required to do so by law. Neither the Company nor its shareholders, officers, and consultants shall be liable for any action and the results of any action taken by any person based on the information contained herein, including, without limitation, the purchase or sale of Company securities. Nothing in this document should be deemed to be medical or other advice of any kind. All images are for illustrative purposes only. IzoView is not yet approved for sale.
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