Marci Norton and Olivia Osburn wrote an article in Healthcare Innovation about how artificial intelligence (AI) "is actively shaping clinical decision-making and is increasingly embedded in the medical devices that clinicians rely on every day."

"The majority of these devices are concentrated in radiology and image‑analysis applications, followed by cardiology, neurology, and other diagnostic specialties, according to the U.S. Food and Drug Administration (FDA)," Marci and Olivia explained. "From radiology workflows to surgical navigation systems, AI-enabled tools are influencing diagnoses, guiding procedures, and, in some cases, determining the trajectory of patient care in real time. For healthcare leaders focused on advancing value-based care, this shift presents both a strategic opportunity and a growing source of clinical and enterprise risk."

"The scale of AI adoption is striking," they continued. "In 2015, the FDA had authorized only a small number of AI-enabled medical devices. By the end of 2025, that number had surpassed 1,400, with nearly 300 devices authorized by the FDA in a single year. Most of these devices were authorized through the 510(k) clearance pathway, which enables faster market entry by demonstrating substantial equivalence to existing technologies. Adoption has been concentrated in medical imaging, where three-quarters of AI-enabled devices are currently used, but use in procedural settings and real-time clinical decision support is rapidly expanding."

Click here to read their full article: AI at the Bedside: Scaling Innovation Without Compromising Patient Safety

Healthcare Innovation reaches an audience of executives, clinicians, and other decision-makers at health systems, hospitals, and other providers.