07/08/2024

Tempus receives U.S. FDA 510(k) clearance for Tempus ECG-AF,
an AI-based algorithm that identifies patients at increased risk of AFib

Tempus AI, Inc. (NASDAQ: TEM), a leader in AI and precision medicine, announced it has received 510(k) clearance from the FDA for its Tempus ECG-AF device. This AI-based algorithm helps identify patients who may be at increased risk of atrial fibrillation/flutter (AF), marking the first FDA clearance for an AF indication in the "cardiovascular machine learning-based notification software" category.

AF, a common cause of stroke, affects millions of people and can be challenging to diagnose. This clearance solidifies Tempus’ innovative approach to offering clinicians AI-based clinical solutions that support the potential for earlier identification of cardiovascular disease and conditions. ECG-AF is the first of a suite of next generation diagnostics that Tempus has designed to identify patients at risk for a variety of cardiovascular conditions.

Read the full press release here.

 

See our Research in ECG based Cardiology Algorithms:

Our Experts

Brandon Fornwalt, MD, PhD

Senior Vice President of Cardiology, Tempus

John Pfeifer, MD, MPH

Vice President of Clinical Cardiology, Tempus

Related Content

View more
  • post image
    08/29/2025

    Precision Medicine 2.0: The operating system for oncology R&D

    This white paper addresses the persistent challenges in oncology R&D, demonstrating how precision medicine has evolved into a new paradigm built on systems-level understanding and AI-driven insights. Download for a comprehensive overview of Precision Medicine 2.0, its core scientific pillars, enabling technologies, and how R&D organizations can leverage this integrated approach to optimize their cancer research.

    Read more
  • post image
    08/15/2025

    Tempus’ data solutions for commercialization

    Learn how our multimodal real-world data can help quantify new market opportunities, build your value story, and inform your market access strategy.

    Read more
  • post image
    08/15/2025

    Tempus’ data solutions for clinical development

    Learn how our multimodal real-world data can help you optimize trial design, mitigate risk, and inform your companion diagnostic strategy.

    Read more