Business
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.
About this update from Cardiac Biotech Solutions Inc.
[{"type":"text","content":"Updated product to include significant operating improvements and material design advances over the current offeringESCONDIDO, 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 pla...