FDA 510(k) De Novo & QML Neuroimaging for Alzheimer’s 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):

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):
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,

CEO Kevin Kawchak

ChemicalQDevice

November 17th, 2022