Artificial intelligence-enabled medical devices with no clinical validation were more likely to be the subject of recalls, according to a study published in JAMA Health Forum. The study, published on ...

Bringing Portable Fluorescence Imaging to Any Smart Device that Fits in Clinical Workflows. This clearance marks a ...

Medical devices using AI were rarely indicated for children and were limited to a few specialties. Pediatric devices faced ...

Oracle Health has introduced a new three-tier validation framework for medical devices that it says standardizes approaches to validating connectivity, functionality and workflow alignment and will ...

AI is transforming health care, but a new study from researchers at Johns Hopkins, Georgetown, and Yale suggests we might be moving too fast to integrate the technology into clinical settings. Their ...

Vektor Medical, a medical technology company transforming cardiac arrhythmia care, announced key milestones achieved in 2025, a year defined by progress, innovation, and growth. Vektor’s flagship ...

Medical device equipment manufacturers work in an environment where product quality isn't just a competitive advantage, it's a regulatory necessity with direct implications for patient safety. As ...

While FDA guidance (“Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices”) states that ...

Bringing a medical device to clinical trial is one of the most significant milestones in any development journey. Yet terms ...

Oracle Health has launched a device validation program aimed at standardizing how medical devices connect to health systems and electronic health records. The company introduced the Oracle Health ...