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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.宣布FDA 510(K)提交增强型MyCam心脏事件监测器
Accesswire ·  2022/09/06 18:05

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

更新了产品,在当前产品的基础上进行了重大操作改进和材料设计改进

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).

加利福尼亚州埃斯孔迪多/ACCESSWIRE/2022年9月6日/CB Science。非侵入性非侵入性动态心脏监护仪产品和服务的设计商、制造商和分销商CBSC公司(以下简称“CBSC”或“公司”)今天宣布,它已经完成了其最新的myCam心脏事件监护仪设计的监管测试阶段,并已正式向美国食品和药物管理局(FDA)提交了510(K)申请上市许可。

"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.首席执行官查尔斯·马丁说:“正如之前宣布的那样,这种新的更新的myCam产品设计保持了我们最初最先进的自动触发设备提供的所有核心功能,同时提供了降低功耗、增强引线屏蔽、改善信号质量,以及可能最重要的是,卓越的材料采购选择,有效地将关键部件的交货期缩短了50%以上。一旦获得FDA的批准,推出这种增强的产品设计将使公司能够生产出更好、更具成本效益的设计,从而提高我们在未来非卧床心脏远程医疗设备市场的竞争地位。“

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.

该公司预计FDA将在大约90至120天内对这份510(K)提交的申请做出回应。在审查过程中,CBSC期待着与FDA合作,共同努力尽快获得MyCam新产品的上市许可。一旦获得FDA的批准,该公司打算在国内以及整个亚洲、拉丁美洲、印度和中东的国际市场销售该设备,这些地区都需要FDA认证。

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.

随着更多新情况的出现,CB Science,Inc.计划通过新闻稿和监管文件及时发布公告,让其股东、行业参与者和公开市场了解情况。

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.

关于CB Science,Inc.
CB Science,Inc.通过其国内和国际子公司,在动态非侵入性心脏监测领域提供创新的产品和服务。我们的FDA和CE批准的EKG设备、基于云的交互式采集软件和适用于iOS和Android平台的智能手机应用程序为有异常心律风险的患者提供了更好的遵从性,并为医生提供了更准确的信息。

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

公司联系信息:
电话:(888)225-0870
电子邮件:General Query:Info@cbScience ficinc.com
投资者咨询:Robert Hesse-dorchco.bh@gmail.com
关注CBSC:Twitter、Facebook、Instagram、LinkedIn、YouTube和时事通讯

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.

这一信息披露可能包含《1995年私人证券诉讼法案》所涵盖的前瞻性陈述。这些前瞻性陈述涉及推出或增强我们的服务和产品的计划和时间,有关未来市场状况、供需状况的陈述,以及本新闻稿中包含的其他预期、意图和计划,这些都不是历史事实,涉及风险和不确定性。我们对未来收入的预期取决于我们开发和提供产品和服务的能力,这些产品和服务可能不是我们今天生产的,而且符合规定的规格。在本新闻稿中使用的“计划”、“预期”、“相信”以及类似的表述通常代表前瞻性陈述。这些声明反映了我们目前的预期。它们受到许多风险和不确定性的影响,包括但不限于技术的变化和普遍存在的市场的变化。本新闻稿包括1933年《证券法》第27A节和1934年《证券法》第27E节所指的前瞻性陈述。本新闻稿中包含的非历史事实的陈述可能被视为前瞻性陈述。请投资者注意,前瞻性陈述本质上是不确定的。由于某些风险和不确定因素,包括但不限于获得融资以及监管机构和股东对预期行动的批准的能力,实际业绩和结果可能与本文预测或建议的情况大不相同。

SOURCE: CB Scientific, Inc.

资料来源:CB Science,Inc.


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