While off-label use may be permissible, contraindicated use still has a strong regulatory boundary as reinforced by FDA guidance finalized in 2025.

A recent survey of 2,000 UK patients found one in four patients (24%) already use AI for health guidance, and nearly one in ...

In the current Cyber Threat environment, companies must have strong cyber liability insurance. Policies must specifically account for cyber-physical risks and the substantial costs of post-market ...

omico’s new facility expands its global production capacity and enhances its ability to be close to customers without taking ...

When hardware and firmware are developed by separate vendors, diagnosing issues like symptoms of non-performance becomes slower and more complex. Unified engineering teams are essential to MedTech ...

A digital companion, purpose-built for surgical patients’ pre- and post-operative journeys, is now an imperative for providers, payers, and medtech leaders aiming to achieve competitive ...

The MedTech industry has seen significant growth and raised expectations as it adapts to evolving healthcare needs in the wake of the COVID-19 pandemic. The industry’s ability to make technology a ...

Several alternatives exist to obtain FDA approval of artificial intelligence-enabled medical technology. Determining the best approach for a new device will require an awareness of each pathway’s ...

The use of Radio-Frequency Identification (RFID) technology in healthcare, particularly within closed-loop systems, presents complexities, including potential limitations on interoperability that can ...

Infographics can propel MedTech research and campaigns and enhance the user experience. Here Fabricio Pamplona, co-founder of online infographic maker for scientists Mind the Graph, explores the power ...

For “Systematic Testing of a Ventilator Remote Control System Towards Safe Use in Tele-Critical Care and Prolonged Care,” researchers developed a prototype system for network-based far remote-control ...

The Investigational New Drug (IND) application and the New Drug Application (NDA) stages are critical milestones in drug development, but they are different applications. Developers and sponsors must ...