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
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.
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SOURCE: CB Scientific, Inc.