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

Rhea-AI Summary

CB Scientific (OTCQB:CBSC) has completed regulatory testing for its enhanced myCam cardiac event monitor and submitted a 510(k) application to the FDA for market clearance. The updated design offers reduced power consumption, improved signal quality, and superior materials that cut component lead times by over 50%. The company expects FDA feedback within 90 to 120 days. Following clearance, CBSC aims to market the device in the U.S. and internationally, including Asia and Latin America, enhancing its competitive position in the cardiac monitoring market.

Positive

• Submission of 510(k) application to FDA for myCam cardiac event monitor.
• Improved product design with reduced power consumption and enhanced signal quality.
• Component lead times reduced by over 50%.
• Expected FDA response within 90-120 days, facilitating timely market entry.

Negative

• Regulatory approval is uncertain and could face delays.
• Market risks due to competition in the ambulatory cardiac monitoring sector.

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

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).

"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."

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.

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
Follow CBSC: Twitter, Facebook, Instagram, LinkedIn, YouTube, and Newsletter

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.

View source version on accesswire.com:
https://www.accesswire.com/714742/CB-Scientific-Inc-Announces-FDA-510k-Submission-of-Enhanced-myCam-Cardiac-Event-Monitor

FAQ

What is the latest update on CBSC's myCam cardiac event monitor?

CBSC has submitted a 510(k) application to the FDA for its enhanced myCam cardiac event monitor.

What improvements have been made to the myCam device design?

The updated myCam design features reduced power consumption, improved signal quality, and shorter component lead times.

When can we expect a response from the FDA regarding the myCam submission?

CBSC anticipates a response from the FDA within 90 to 120 days.

In which markets does CBSC plan to sell the myCam after FDA clearance?

CBSC plans to market the myCam device in the U.S. and internationally, including Asia, Latin America, India, and the Middle East.