CB Scientific, Inc. 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). 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.