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CB Scientific, Inc. Announces FDA 510(k) Submission of Enhanced MyCam Cardiac Event Monitor

CB Scientific, Inc. Announces FDA 510(k) Submission of Enhanced MyCam Cardiac Event Monitor

CB Science,Inc.宣佈FDA 510(K)提交增強型MyCam心臟事件監測器
Accesswire ·  2022/09/06 19:05

Updated product to include significant operating improvements and material design advances over the current offering

更新了產品,在當前產品的基礎上進行了重大操作改進和材料設計改進

ESCONDIDO, CA / ACCESSWIRE / September 6, 2022 / CB Scientific. Inc.(OTCQB:CBSC) ("CBSC" or the "Company"), a designer, manufacturer and distributor of non-invasive ambulatory cardiac monitoring products and services, today announced that it has completed the regulatory testing phase of its latest myCam cardiac event monitor design and has formally tendered a 510(k) submission for Clearance to Market to the U.S. Food and Drug Administration (FDA).

加利福尼亞州埃斯孔迪多/ACCESSWIRE/2022年9月6日/CB Science。非侵入性非侵入性動態心臟監護儀產品和服務的設計商、製造商和分銷商CBSC公司(以下簡稱“CBSC”或“公司”)今天宣佈,它已經完成了其最新的myCam心臟事件監護儀設計的監管測試階段,並已正式向美國食品和藥物管理局(FDA)提交了510(K)申請上市許可。

"As previously announced, this new updated myCam product design maintains all the core functionality that our original state-of-the-art auto-trigger device offers while providing reduced power consumption, enhanced lead wire shielding, improved signal quality, and perhaps most important, superior materials sourcing options that effectively shrink critical component lead times by over 50%," said Charles Martin, Chief Executive Officer of CB Scientific, Inc. "Once cleared by the FDA, introduction of this enhanced product design will allow the Company to produce a superior, more cost-effective design that will improve our competitive position in the ambulatory cardiac remote medical device market going forward."

CB Science,Inc.首席執行官查爾斯·馬丁説:“正如之前宣佈的那樣,這種新的更新的myCam產品設計保持了我們最初最先進的自動觸發設備提供的所有核心功能,同時提供了降低功耗、增強引線屏蔽、改善信號質量,以及可能最重要的是,卓越的材料採購選擇,有效地將關鍵部件的交貨期縮短了50%以上。一旦獲得FDA的批准,推出這種增強的產品設計將使公司能夠生產出更好、更具成本效益的設計,從而提高我們在未來非卧牀心臟遠程醫療設備市場的競爭地位。“

The company anticipates a response from the FDA for this 510(k) submission in approximately 90 to 120 days. During the review process, CBSC looks forward to collaborating with the FDA in a concerted effort to obtain Clearance to Market for the new myCam product as quickly as possible. Upon receiving FDA clearance, the company intends to market the device domestically, as well as internationally throughout Asia, Latin America, India and the Middle East, each of which require FDA certification.

該公司預計FDA將在大約90至120天內對這份510(K)提交的申請做出迴應。在審查過程中,CBSC期待着與FDA合作,共同努力儘快獲得MyCam新產品的上市許可。一旦獲得FDA的批准,該公司打算在國內以及整個亞洲、拉丁美洲、印度和中東的國際市場銷售該設備,這些地區都需要FDA認證。

As additional new developments occur, CB Scientific, Inc. plans to make timely announcements through press releases and regulatory filings to keep its shareholders, industry participants, and the public markets informed.

隨着更多新情況的出現,CB Science,Inc.計劃通過新聞稿和監管文件及時發佈公告,讓其股東、行業參與者和公開市場瞭解情況。

About CB Scientific, Inc.
CB Scientific, Inc., through its domestic and international subsidiaries, provides innovative products and services in the ambulatory non-invasive cardiac monitoring space. Our FDA and CE cleared EKG devices, interactive cloud-based acquisition software, and smartphone apps for both iOS and Android platforms provide improved compliance for patients at risk of abnormal heart rhythms, as well as more accurate information for physicians.

關於CB Science,Inc.
CB Science,Inc.通過其國內和國際子公司,在動態非侵入性心臟監測領域提供創新的產品和服務。我們的FDA和CE批准的EKG設備、基於雲的交互式採集軟件和適用於iOS和Android平臺的智能手機應用程序為有異常心律風險的患者提供了更好的遵從性,併為醫生提供了更準確的信息。

Company Contact Information:
Telephone: (888) 225-0870
Email: General Inquiries: info@cbscientificinc.com
Investor Inquiries: Robert Hesse - dorchco.bh@gmail.com
Follow CBSC: Twitter, Facebook, Instagram, LinkedIn, YouTube, and Newsletter

公司聯繫信息:
電話:(888)225-0870
電子郵件:General Query:Info@cbScience ficinc.com
投資者諮詢:Robert Hesse-dorchco.bh@gmail.com
關注CBSC:Twitter、Facebook、Instagram、LinkedIn、YouTube和時事通訊

This information disclosure may contain forward-looking statements covered within the meaning of the Private Securities Litigation Act of 1995. These forward-looking statements relate to, among other things, plans and timing for the introduction or enhancement of our services and products, statements about future market conditions, supply and demand conditions, and other expectations, intentions, and plans contained in this press release that are not historical fact and involve risks and uncertainties. Our expectations regarding future revenues depend upon our ability to develop and supply products and services that we may not produce today and that meet defined specifications. When used in this press release, the words "plan," "expect," "believe," and similar expressions generally identify forward-looking statements. These statements reflect our current expectations. They are subject to a number of risks and uncertainties, including, but not limited to, changes in technology and changes in pervasive markets. This release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 27E of the Securities Act of 1934. Statements contained in this release that are not historical facts may be deemed to be forward-looking statements. Investors are cautioned that forward-looking statements are inherently uncertain. Actual performance and results may differ materially from that projected or suggested herein due to certain risks and uncertainties, including, without limitation, the ability to obtain financing and regulatory and shareholder approval for anticipated actions.

這一信息披露可能包含《1995年私人證券訴訟法案》所涵蓋的前瞻性陳述。這些前瞻性陳述涉及推出或增強我們的服務和產品的計劃和時間,有關未來市場狀況、供需狀況的陳述,以及本新聞稿中包含的其他預期、意圖和計劃,這些都不是歷史事實,涉及風險和不確定性。我們對未來收入的預期取決於我們開發和提供產品和服務的能力,這些產品和服務可能不是我們今天生產的,而且符合規定的規格。在本新聞稿中使用的“計劃”、“預期”、“相信”以及類似的表述通常代表前瞻性陳述。這些聲明反映了我們目前的預期。它們受到許多風險和不確定性的影響,包括但不限於技術的變化和普遍存在的市場的變化。本新聞稿包括1933年《證券法》第27A節和1934年《證券法》第27E節所指的前瞻性陳述。本新聞稿中包含的非歷史事實的陳述可能被視為前瞻性陳述。請投資者注意,前瞻性陳述本質上是不確定的。由於某些風險和不確定因素,包括但不限於獲得融資以及監管機構和股東對預期行動的批准的能力,實際業績和結果可能與本文預測或建議的情況大不相同。

SOURCE: CB Scientific, Inc.

資料來源:CB Science,Inc.


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