FDA revised guidance documents for low-risk wellness products and clinical decision software, clarifying regulatory ...

The report is based on a series of traceability readiness tabletop exercises held with industry between March 9 and April 1.

The top observations identified in Form 483 reports from inspections conducted under the recently implemented Quality Management System Regulation (QMSR) include risk management, outsourcing and ...

The Food and Drug Administration has approved a clinical AI technology used to detect early signs of sepsis, the Targeted Real-Time Early Warning System. “Few clinical AI systems can reason across the ...

An early warning system for sepsis, one of the deadliest infections for hospital patients, has been approved for use by the U.S. Food and Drug Administration, one of the first AI-based medical tools ...

An early warning system for sepsis, one of the deadliest infections for hospital patients, has been approved for use by the FDA, one of the first AI-based medical tools to get clearance. The tool, ...

Johns Hopokins computer scientist Suchi Saria began translating her lab’s research into a real-world system after losing her nephew to sepsis in 2017. An early warning system for sepsis, one of the ...

Luminoah, a Charlottesville-based medical technology company, announced last week that it has received clearance from the U.S. Food and Drug Administration for an enteral feeding system designed to ...

The July 2026 advisory review could reopen compounding pathways for peptides previously curtailed in 2023 over immunogenicity, toxicity, impurity risk, and inadequate human clinical evidence.

As AI and high‑performance computing systems continue to scale, memory bandwidth has emerged as a primary system‑level constraint. Larger models, higher compute density, and increasingly complex multi ...

FDA approval was supported by the one-year results of the TRIOMPHE Investigational Device Exemption (IDE) Study evaluating the NEXUS® System shown to effectively treat aortic arch disease, including ...