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b/R&D/064 AI Approvals.md |
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[FDA AI/ML Approvals, Basis for QNN Neuroimaging](https://www.chemicalqdevice.com/fda-aiml-approvals-basis-for-qnn-neuroimaging) PDF + Discussion 1/19/23. |
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Dear Healthcare Colleague, |
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FDA approved the First high technology "Deep Learning" Medical algorithm in 2017. Since then, Neuroimaging/Neuroradiology Deep Learning software continues to evolve. 1, 2 |
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FDA Medical Device submissions require adherence to ISO and IEC Standards. (2) ISO/IEC Quantum security standards in progress are a Landmark for other fields such as Medical. 3, 4 |
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The December 2022 White House Law now requires Federal Agencies to implement technologies for quantum defence. Also in December, The White House has announced (2) Individuals whose background is in Quantum and Imaging. 5, 6 |
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"..The underlying motivation was to build a long-term company whose final goal was to better the lives of people, to alleviate so much pain in this world." - Unicorn Founder, Osman Kibar. 7 |
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References |
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[1](https://www.accessdata.fda.gov/cdrh_docs/pdf16/K163253.pdf) |
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[2](https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-and-machine-learning-aiml-enabled-medical-devices) |
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[3](https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/division-standards-and-conformity-assessment) |
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[4](https://www.iso.org/foresight/computing.html#quantum-technologies) |
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[5](https://www.congress.gov/bill/117th-congress/house-bill/7535) |
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[6](https://www.whitehouse.gov/briefing-room/statements-releases/2022/12/09/president-biden-announces-key-appointments-to-boards-and-commissions-14/) |
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[7](https://www.forbes.com/sites/matthewherper/2016/04/13/the-god-pill/?utm_source=FBPAGE&utm_medium=social&utm_content=846229152&utm_campaign=sprinklrForbesMainFB&sh=11e26d7b5757) |
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Sincerely, <br> |
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CEO Kevin Kawchak <br> |
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ChemicalQDevice <br> |
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January 21st, 2023 <br> |