February 23, 2021
My-Cardia (USA) Inc. is a wholly owned subsidiary of CB Scientific and provides ambulatory Cardiac Event Monitoring services in the US as well as provides the device, software, smartphone app, IT support, technical and clinical support for all international distributor operations and Chinese locations under our umbrella.
Secured US FDA 510K Registration through My-Cardia (USA) Inc. with authorizations for Singapore, Malaysia (www.mycardia.com.my) and Thailand (www.mycardiathailand.com) distributors, and the My-Cam pre-registration numbers from National Medical Product Administration ‘NMPA’ (formerly China Food and Drug Administration ‘CFDA’). Thailand is targeted to launch in September 2020, followed by Malaysia in October and Singapore in December.
CBSC products have passed CE (Cardiac Event) certification and other international quality system certifications.
CBSC has been conducting device trial seminars across China to promote awareness of CBSC’s device called the My-Cam.
Our targeted market in the US is the Ambulatory Cardiac Diagnostic Monitoring space. Plans include the addition of an Independent Diagnostic Testing Facility (IDTF) and our own Medical Device Manufacturer to our company. Securing these two entities will provide the opportunity to offer additional Remote Cardiac Monitoring modalities and services which will place CBSC more firmly into the $6.9B US market competing directly against the likes of Biotelemetry (NASDAQ: BEAT) and iRhythm (NASDAQ: IRTC).