Izotropic Confirms FDA Pre-Submission Meeting Date
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.
温哥华,不列颠哥伦比亚省-(Newsfile Corp.-2023年9月27日)-Izotrotic公司(CSE:以藏)(OTCQB:IZOZF)(FSE:1R3)(“各向同性“或”公司IzoView是一家将CT(计算机断层成像)成像系统IzoView商业化的医疗设备公司,IzoView是一种产生解剖图像的CT(计算机断层成像)成像系统,它在乳房成像中的第一个应用是产生解剖图像。该公司今天宣布,它已经确认了定于2023年10月25日与美国食品和药物管理局(FDA)举行的提交前会议日期。
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.
继2023年9月6日发布新闻稿后,Izotroy完成了向FDA提交的预提交申请,以巩固其通过510(K)上市前通知提交为IzoView作为II类设备争取市场许可的计划。
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.
即将举行的会议的目的是讨论申请、获得反馈并确认下一步行动。会议将在马里兰州的罗克维尔举行,Izotroy公司的管理、技术和工程团队成员及其FDA顾问Matrix Medical Devices将出席会议。
The Company will issue a news release in due course after the meeting to report on its progress.
公司将在会后适当时候发布新闻稿,报告其进展情况。
ON BEHALF OF THE BOARD
我代表董事会
Mr. Robert Thast, CEO
Cell: 604-220-5031
首席执行官Robert Tast先生
电话:604-220-5031
Contact:
Email: info@izocorp.com
Toll Free: 1-833-IZOCORP ext.1
联系方式:
电子邮件:info@izocorp.com
免费电话:1-833-IZOCORP分机1
About Izotropic
More information about Izotropic Corporation can be found on its website at izocorp.com and by reviewing its profile on SEDAR at sedar.com.
关于等方向性
欲了解有关Izotroy公司的更多信息,请访问公司网站:izocorp.com,或查看公司在SEDAR上的简介:sedar.com。
Forward-Looking Statements
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.
前瞻性陈述
本文档可能包含“前瞻性陈述”,这些陈述基于对公司管理层、业务的当前估计、假设、预测和预期,以及对公司运营所处的相关市场和经济环境的了解。在可能的情况下,本公司已尝试通过使用下列词语来识别此类信息和陈述:“预期”、“相信”、“设想”、“估计”、“预期”、“打算”、“可能”、“计划”、“预测”、“项目”、“目标”、“潜在”、“将”、“将”、“可能”、“可能”、“应该”、“继续,关于未来事件、趋势或前景或未来经营或财务业绩的任何讨论,“考虑”及其他类似表述及其派生,尽管并不是所有前瞻性表述都包含这些识别词语。
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.
这些陈述不是对业绩的保证,涉及风险,包括与资本要求和难以控制或预测的不确定性有关的风险,因此,它们可能导致公司未来活动的结果与此类陈述的内容和影响大不相同。前瞻性陈述仅在作出之日起具有相关性,公司没有义务更新或修改任何前瞻性陈述,以反映新的信息或未来事件或情况的发生,除非法律另有要求。本公司及其股东、高级管理人员和顾问均不对任何人根据本文所含信息采取的任何行动以及任何行动的结果负责,包括但不限于购买或出售公司证券。本文档中的任何内容都不应被视为任何类型的医疗或其他建议。所有图片仅用于说明目的。IzoView尚未获准出售。
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要查看本新闻稿的源版本,请访问