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 ...

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

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 ...

Artificial intelligence (AI) has practically limitless applications in healthcare, ranging from auto-drafting patient messages in MyChart to optimizing organ transplantation and improving tumor ...

Legacy medical devices face growing scrutiny as regulators push for stronger cybersecurity, transparency and risk management.

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 ...

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 ...

Anyone who has worked inside a MedTech organization knows that bringing a new device to market is not a single sprint. It is a marathon made up of dozens of short, fast, sometimes messy races — market ...

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

Cybersecurity has evolved from a secondary software concern to a core design requirement in connected medical devices. The ...