October 03, 2024
October 03, 2024
my-Cardia (USA) Inc. is a wholly owned subsidiary of CB Scientific, Inc., providing ambulatory cardiac event monitoring services in the U.S. The subsidiary also supplies devices, software, smartphone apps, IT support, and technical and clinical services to our international distributors and partners, including Chinese locations.
CB Scientific, Inc. has been conducting device trial seminars across China to raise awareness of its myCam device. These trials are part of our efforts to expand into the Chinese market.
CB Scientific, Inc. has secured US FDA 510K Registration for our products through my-Cardia (USA) Inc. and obtained authorizations for distributors in Singapore, Malaysia, and Thailand. The myCam device is also in the pre-registration phase with the National Medical Product Administration (NMPA) in China. Our products have passed CE certification, ensuring compliance with international quality standards.
Our primary target market in the U.S. is the Ambulatory Cardiac Diagnostic Monitoring space, a sector with a projected value of $6.9 billion. CB Scientific, Inc. plans to establish an Independent Diagnostic Testing Facility (IDTF) and our own medical device manufacturing operations. This will allow us to offer additional remote cardiac monitoring services, enhancing our position in the market and enabling us to compete directly with industry leaders such as Biotelemetry (NASDAQ: BEAT) and iRhythm (NASDAQ: IRTC).
Our products are available through authorized distributors in Thailand, Malaysia, Singapore, Indonesia, Hong Kong, Macau, and Canada, further broadening our global reach in cardiac monitoring technology.
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