CB Scientific, Inc. Enters Regulatory Testing Phase for Updated myCam Cardiac Event Monitoring Device
CB Scientific, Inc. (OTCQB:CBSC) has announced it has entered the regulatory testing phase for its enhanced myCam cardiac event monitoring device, aiming for FDA 510(k) clearance. The new myCam features improved power consumption, lead wire shielding, signal quality, and cost-effective sourcing, maintaining core functionalities while enhancing market competitiveness. Expected submission for FDA approval is imminent, with product delivery plans for Asia, Latin America, and the Middle East upon clearance.
- Enters regulatory testing phase for updated myCam device.
- Enhanced myCam includes improved power consumption and signal quality.
- Anticipates FDA 510(k) submission to facilitate market entry.
- Regulatory approval timeline and market entry remain uncertain.
Enhanced product to include significant operating enhancements and material design advances over the current offering
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).
"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."
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.
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.
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.
Company Contact Information:
Telephone: (888) 225-0870
Email: General Inquiries: info@cbscientificinc.com
Investor Inquiries: Robert Hesse - dorchco.bh@gmail.com
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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.
SOURCE: CB Scientific, Inc.
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https://www.accesswire.com/702462/CB-Scientific-Inc-Enters-Regulatory-Testing-Phase-for-Updated-myCam-Cardiac-Event-Monitoring-Device
FAQ
What is the significance of the regulatory testing phase for CBSC's myCam device?
When will CB Scientific submit the myCam device for FDA approval?
What improvements does the new myCam device offer compared to the previous version?
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