[FDA 510(k) De Novo & QML Neuroimaging for Alzheimer’s](https://www.chemicalqdevice.com/fda-510kde-novo-qml-neuroimaging-for-alzheimers) PDF + Discussion 11/17/22.

Dear Colleague,

A study into 10 AI/ML FDA Approvals was conducted this week. The main finding was that Post-processing of Existing Medical Images with algorithms was the most common approach. This method mentioned less Regulatory Standards than with more complex physical medical devices. [discussion](https://www.youtube.com/watch?v=UsRKOqn3POA&t=3s)): 

For emerging Quantum Machine Learning (QML) technologies seeking potential approval as a 510(k)/De Novo Class II SaMD, new quantum hardware and software standards may first need to be created by other technical regulatory bodies, such as ISO, IEC, NEMA, ASTM, and ANSI ([short discussion](https://www.youtube.com/watch?v=7BylYBoSvEg)): 

A New ChemicalQDevice Stage I, II, III, IV Strategy was also detailed.

hashtag#endalzheimers, hashtag#endalz, hashtag#qml, hashtag#neuroimaging, hashtag#fda, hashtag#regulation, hashtag#standards, ISO - International Organization for Standardization, IEC (International Electrotechnical Commission), National Electrical Manufacturers Association (NEMA), ASTM International, ANSI Compliance, FDA

Sincerely, <br>

CEO Kevin Kawchak <br>

ChemicalQDevice <br>

November 17th, 2022 <br>