Connected medical devices improve patient care but introduce severe cybersecurity risks that require stringent regulatory ...

Many medical device companies develop software using a traditional waterfall methodology in which each step is taken in sequence: requirements, design, implementation, verification, and validation ...

There has been a surge in academic and business interest in software as a medical device (SaMD). It enables medical professionals to streamline existing medical practices and make innovative medical ...

GE HealthCare continues to lead the industry in artificial intelligence (AI) innovation, topping a U.S. Food and Drug Administration list of AI-enabled medical device authorizations, with 115 ...

For SLAS US 2023, we speak to Guy Starbuck, one of the co-founders at AIQ Global, about how we can utilize AI technology to bring new medical devices to market. Please could you introduce yourself and ...

Software is increasingly used as a medical device, transforming the healthcare industry with the goal of improving patient outcomes. However, developing software as a medical device involves ...

Medical devices have to be designed so that people can use them easily and reliably. Human factors considerations have gained increased attention since the release of FDA's guidance document, Medical ...

The FDA has entered into the federal register a new draft guidance pertaining to "software as a medical device" (SaMD). The guidance is presented as representing the FDA's current thinking on ...

Expertise from Forbes Councils members, operated under license. Opinions expressed are those of the author. In 2023, the MedTech custom medical software development market will continue growing with ...

“Don’t fear the Reaper,” the rock band Blue Öyster Cult famously advised. For many digital health companies, the Food and Drug Administration’s recently revised guidances affecting the classification ...

Claritas NucMed Technologies Ltd (Claritas), a healthcare technology company specializing in state-of-the-art image ...