Izotropic Receives Response From U.S. FDA
Izotropic Receives Response From U.S. FDA
Vancouver, British Columbia--(Newsfile Corp. - January 30, 2024) - 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 characterization of tissue with an application in breast imaging, announces that further to its January 8th disclosure, it has received a response from the U.S. FDA.
不列颠哥伦比亚省温哥华--(Newsfile Corp.-2024 年 1 月 30 日)- Izotropic Corporation(CSE:IZO)(场外交易代码:IZOZF)(FSE:1R3) (”Izotropic“或者”公司“)是一家将CT(计算机断层扫描)成像系统IzoView商业化的医疗器械公司,该公司在乳房成像中应用于乳房成像生成解剖学图像,用于对组织进行非侵入性表征。该公司在1月8日之后宣布第四 披露,它已收到美国食品药品管理局的回应。
The FDA's mammogram and ultrasound team has responded to Izotropic with additional questions regarding its pre-submission seeking definitive guidance on a Class II 510(k) pathway. The FDA had previously agreed in writing to provide a more definitive response to Izotropic within the month of January. Izotropic's management, regulatory, and engineering teams will respond to the FDA's questions and will promptly report the outcomes of the FDA's response once it becomes available.
美国食品和药物管理局的乳房X光检查和超声检查小组已对Izotropic做出了回应,并就其在提交前寻求有关II 510(k)途径的明确指导提出了其他问题。美国食品和药物管理局此前已书面同意在1月份内对Izotropic做出更明确的回应。Izotropic的管理、监管和工程团队将回应FDA的问题,并在FDA的回应结果出炉后立即报告答复结果。
As of the date of this news announcement, there has been no material change to the Company's regulatory plans and no definitive decision provided by the FDA.
截至本新闻公告发布之日,该公司的监管计划没有实质性变化,美国食品和药物管理局也没有提供最终决定。
ON BEHALF OF THE BOARD
代表董事会
Mr. Robert Thast, CEO
Cell: 604-220-5031
首席执行官罗伯特·萨斯特先生
手机:604-220-5031
Contact:
Email: info@izocorp.com
Toll Free: 1-833-IZOCORP ext.1
联系人:
电子邮件:info@izocorp.com
免费电话:1-833-IZOCORP ext.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 Izotropic
有关Izotropic Corporation的更多信息,请访问其网站izocorp.com,也可以在sedar.com上查看其在SEDAR上的个人资料。
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
本文件可能包含 “前瞻性陈述” 的陈述,这些陈述基于公司管理层、业务的当前估计、假设、预测和预期及其对运营所在相关市场和经济环境的了解。公司尽可能尝试使用 “预期”、“相信”、“设想”、“预期”、“预期”、“打算”、“可能”、“可能”、“计划”、“预测”、“项目”、“目标”、“潜力”、“将”、“可能”、“应该”、“继续”、“考虑” 等词语来识别此类信息和陈述尽管并非所有前瞻性陈述都包含这些识别性词语,但与讨论未来事件、趋势或前景或未来运营或财务业绩有关的表述和衍生词。
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 has not yet been approved or cleared for sale.
这些陈述不能保证业绩,涉及风险,包括与资本要求和难以控制或预测的不确定性相关的风险,因此,它们可能导致公司活动的未来业绩与此类陈述的内容和含义存在重大差异。前瞻性陈述仅在发表之日起具有相关性,除非法律另有要求,否则公司没有义务更新或修改任何前瞻性陈述以反映新信息或未来事件或情况的发生。公司及其股东、高级管理人员和顾问均不对任何人根据此处包含的信息采取的任何行动和结果承担责任,包括但不限于购买或出售公司证券。本文件中的任何内容都不应被视为任何形式的医学或其他建议。所有图片仅用于说明目的。izoView尚未获得批准或批准出售。
To view the source version of this press release, please visit
要查看本新闻稿的源版本,请访问