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The FDA has instituted the Quality Management System Regulation (QMSR) to harmonize its previous Quality System Regulation (QSR) with the ISO 13485 international standard.
A global harmonization of medical device regulations is occurring, driven by a desire from regulatory bodies like the FDA to reduce duplicative requirements.
Investment capital that might have previously gone to the medtech sector is now being redirected to AI companies.
Akili offers both a prescription version and an over-the-counter app for its ADHD-focused software as a medical device product.
Medical devices are predicted to become more interconnected and function as a system, driven by convergence with AI and big data technologies.
Continuous glucose monitoring technology, originally developed for diabetics, is now being adopted by consumers for general fitness and wellness purposes.