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.
不列顛哥倫比亞省溫哥華--(Newsfile Corp.-2024 年 1 月 30 日)- Izotropic Corporation(CSE:IZO)(場外交易代碼:IZOZF)(FSE:1R3) (”Izotropic“或者”公司“)是一家將CT(計算機斷層掃描)成像系統IzoView商業化的醫療器械公司,該公司在乳房成像中應用於乳房成像生成解剖學圖像,用於對組織進行非侵入性表徵。該公司在1月8日之後宣佈第四 披露,它已收到美國食品藥品管理局的回應。
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.
美國食品和藥物管理局的乳房X光檢查和超聲檢查小組已對Izotropic做出了回應,並就其在提交前尋求有關II 510(k)途徑的明確指導提出了其他問題。美國食品和藥物管理局此前已書面同意在1月份內對Izotropic做出更明確的回應。Izotropic的管理、監管和工程團隊將回應FDA的問題,並在FDA的回應結果出爐後立即報告答覆結果。
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.
截至本新聞公告發布之日,該公司的監管計劃沒有實質性變化,美國食品和藥物管理局也沒有提供最終決定。
ON BEHALF OF THE BOARD
代表董事會
Mr. Robert Thast, CEO
Cell: 604-220-5031
首席執行官羅伯特·薩斯特先生
手機:604-220-5031
Contact:
Email: info@izocorp.com
Toll Free: 1-833-IZOCORP ext.1
聯繫人:
電子郵件:info@izocorp.com
免費電話: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.
關於 Izotropic
有關Izotropic Corporation的更多信息,請訪問其網站izocorp.com,也可以在sedar.com上查看其在SEDAR上的個人資料。
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.
前瞻性陳述
本文件可能包含 “前瞻性陳述” 的陳述,這些陳述基於公司管理層、業務的當前估計、假設、預測和預期及其對運營所在相關市場和經濟環境的了解。公司儘可能嘗試使用 “預期”、“相信”、“設想”、“預期”、“預期”、“打算”、“可能”、“可能”、“計劃”、“預測”、“項目”、“目標”、“潛力”、“將”、“可能”、“應該”、“繼續”、“考慮” 等詞語來識別此類信息和陳述儘管並非所有前瞻性陳述都包含這些識別性詞語,但與討論未來事件、趨勢或前景或未來運營或財務業績有關的表述和衍生詞。
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.
這些陳述不能保證業績,涉及風險,包括與資本要求和難以控制或預測的不確定性相關的風險,因此,它們可能導致公司活動的未來業績與此類陳述的內容和含義存在重大差異。前瞻性陳述僅在發表之日起具有相關性,除非法律另有要求,否則公司沒有義務更新或修改任何前瞻性陳述以反映新信息或未來事件或情況的發生。公司及其股東、高級管理人員和顧問均不對任何人根據此處包含的信息採取的任何行動和結果承擔責任,包括但不限於購買或出售公司證券。本文件中的任何內容都不應被視爲任何形式的醫學或其他建議。所有圖片僅用於說明目的。izoView尚未獲得批准或批准出售。
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譯文內容由第三人軟體翻譯。