The new Tempus software analyzes resting, non-ambulatory 12-lead ECG recordings to detect signs associated with having a low ...

Tempus AI, Inc. (NASDAQ:TEM) saw its stock rise 3% on Wednesday following the announcement that the company obtained 510(k) ...

The US Food and Drug Administration (FDA) has granted 510(k) clearance for Tempus AI’s ECG-Low (ejection fraction) EF software. This software utilises AI to detect individuals with a low left ...

Tempus AI (TEM) has recently secured FDA clearance for its Tempus ECG-Low EF software, an innovative AI-driven product aiding cardiovascular assessments. This development aligns with TEM’s aim to ...

The FDA cleared Rivanna’s SpineNav-AI image processing software and Accuro 3S diagnostic ultrasound system, according to a July 17 news release. SpineNav-AI is a machine-learning software that ...

For instance, "the backlog of FOIAs ... is enormous," he said. Califf said the FDA has far greater opportunities for improved ...

Marcel Botha discusses whether AI can truly be used to replace laid off human workers at FDA.

The FDA has introduced Elsa, an internal AI tool to review safety data, identify labeling issues, and prioritize inspections, ...

FDA’s Broader AI Goals. The launch of Elsa is part of a broader “AI-forward” strategy. In January 2025, the agency issued a draft guidance on considerations for the use of AI to support ...

On June 2, the FDA dropped the other shoe, saying it had launched a generative AI tool called “Elsa” to help scientific reviewers and investigators work more efficiently.