Sadly be 18 months to 2 years away to have a device ready to go. Even with accelerated approval category 3 medical device approval is complex, not just about the technology being accurate, companies need to demonstrate quality manufacturing processes. Materials used for durability and consistency, ability to sterilise etc etc. Partnering with a company that has a track record of medical device manufacturing would certainly speed up the process.
Ann: AGM Address and Presentation, page-382
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