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Artificial intelligence (AI) and real-world imaging data (RWiD) are fundamentally reshaping and accelerating regulatory approval for medical devices. By delivering more effective, accurate, and transparent regulatory efficiency to a historically manual, slow-motion approach, AI and RWiD are fundamentally changing the regulatory landscape. AI gives the ability to automate functions, reliability, predict, and approve compliance in near real-time, ultimately shortening approval time and error rate. RWiD integrates all of this rich, real-world data into the regulatory review process, amplifying confidence in the safety and effectiveness of devices, while allowing for expedited access to the marketplace. Ultimately, the administrative functions of device development, or regulatory submissions, are transformed by the convergence of AI and RWiD. Market access, innovation, and patient outcomes are all measurably enhanced through monitoring of device performance, clinical utility, and automatic...

The introduction of AI (Artificial Intelligence) has invaded every industry, enhancing outcomes particularly in healthcare. AI in healthcare provides numerous benefits, the major one being precise diagnosis, which leads to better decision making. AI models in healthcare lead to better diagnosis and treatment plans, ultimately leading to better overall healthcare. One aspect of healthcare that contributes to a vast amount of data generation is medical imaging. And owing to huge volumes, it has encouraged professionals to embrace technologies like AI for the management of this data. AI also helps access the rich detail hidden within imaging data. Medical imaging data, when used to develop healthcare AI models, supports important steps like diagnosis and treatment planning. For these reasons, AI is coming forward as a leading solution, one that could transform medical research. For instance, AI diagnostics in breast cancer through mammography scans have led to earlier diagnosis. AI models...