In a recent article titled “FDA Perspective on the Regulation of Artificial Intelligence in Health Care and Biomedicine,” published in JAMA by three senior FDA officials, Prenosis’ Sepsis ImmunoScore™ was highlighted as a pivotal example of an AI innovation successfully navigating the FDA’s regulatory process. JAMA, the world’s most widely circulated medical journal, provides an influential platform for discussing critical healthcare advancements, underscoring the significance of this recognition for the Sepsis ImmunoScore™—the first FDA-authorized AI diagnostic for sepsis.
As the FDA focuses on ensuring that AI tools are safe, effective, and trustworthy, Prenosis is honored to be acknowledged for its commitment to these priorities. Following the FDA framework not only ensures safety and efficacy but also drives meaningful innovation.
We at Prenosis are proud to lead this movement, pushing precision medicine to become the standard of care for serious hospital conditions. Earning FDA authorization for the Sepsis ImmunoScore™ through the De Novo pathway—a more rigorous process than the 510(k) approval, which relies on existing predicate devices—reflects our dedication to regulatory excellence, safety, and innovation. This achievement firmly establishes the Sepsis ImmunoScore™ as a groundbreaking AI-powered tool for sepsis diagnostics.
