The FDA's draft guidance on AI-enabled medical devices highlights a revolutionary change in the regulatory environment as it relates to MedTech. The draft guidance provides a structured but flexible path to creatively merge innovation and patient safety. AI-enabled medical devices, and the processes that enable them, are transforming healthcare—from the early use of diagnostics to revolutionary use in surgical settings to enhance precision medicine and patient safety. The FDA draft guidance listed key actionable pathways providers, manufacturers, hospitals, patients, and investors could use, such as precision control and clinical protocols (PCCPs) and Good Machine Learning Practice (GMLP). It included guidance on the complexities of adaptive AI, the world-wide aligned regulation of adaptive AI in healthcare, and suggested early engagement with the FDA to simplify an often, cumbersome compliance journey to market for many companies. While there is a palpable, rising global momentum for innovation from developers, stakeholders must be trusted partners and adopt a proactive, transparent, and collegial approach. Navigating through this evolving space is not just about regulatory compliance, it is about developing the future of healthcare that is ethical, scalable, and above all trustworthy. The guidance illuminates a path to innovation that is just not disruptive, but meaningfully and responsibly disruptive within the regulatory environment.