CB Scientific, Inc. Enters Regulatory Testing Phase for Updated myCam Cardiac Event Monitoring Device
CB Scientific, Inc. Enters Regulatory Testing Phase for Updated myCam Cardiac Event Monitoring Device
Enhanced product to include significant operating enhancements and material design advances over the current offering
與當前產品相比,增強的產品包括顯著的運營增強和材料設計改進
ESCONDIDO, CA / ACCESSWIRE / May 24, 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 entered the regulatory testing phase for its updated myCam cardiac event monitoring device. Regulatory testing not only demonstrates the myCam product's safety and efficacy but also represents an important milestone towards the company's efforts to obtain 510(k) "Clearance to Market" for the device from the United States Food and Drug Administration (FDA).
加利福尼亞州埃斯孔迪多/ACCESSWIRE/2022年5月24日/CB Science。非侵入性動態心臟監測產品和服務的設計商、製造商和分銷商CBSC(場外交易市場代碼:CBSC)(“CBSC”或“公司”)今天宣佈,其最新的myCam心臟事件監測設備已進入監管測試階段。監管測試不僅證明瞭myCam產品的安全性和有效性,還代表着該公司努力使該設備獲得美國食品和藥物管理局(FDA)的510(K)“上市許可”的一個重要里程碑。
"The enhanced design of our new myCam product provides improved power consumption, enhanced lead wire shielding, superior signal quality, and more cost-effective part sourcing," said Charles Martin, Chief Executive Officer of CB Scientific, Inc. "While this latest myCam product design maintains all of the core functionality our previous state-of-the-art auto-trigger device offers, it will most definitely better position the Company to compete effectively in the market going forward."
CB Science,Inc.首席執行官查爾斯·馬丁説:“我們新MyCam產品的改進設計提供了更高的功耗、更好的引線屏蔽、更高的信號質量和更具成本效益的部件採購。雖然最新的MyCam產品設計保持了我們以前最先進的自動觸發設備提供的所有核心功能,但它肯定會使公司在未來的市場中更有效地競爭。“
The company anticipates the new myCam 510(k) submission will take place in the coming weeks, and once it receives regulatory clearance from the FDA the company expects to produce and deliver the product both domestically and internationally to markets such as Asia, Latin America, and the Middle East, each of which requires FDA certification.
該公司預計,新的myCam 510(K)將在未來幾周內提交,一旦獲得FDA的監管批准,該公司預計將在國內和國際上生產並向亞洲、拉丁美洲和中東等市場交付產品,這些市場中的每一個都需要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.
關於CB Science,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.
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:
公司聯繫信息:
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
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.