On January 7, 2025, FDA published “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations; Draft Guidance for Industry and Food and ...

Finally, the terminology shift worth flagging is QMSR replacing the “Design History File” with “Design and Development File”, ...

Sponsors of AI-enabled devices should engage with the FDA early to ensure that the testing to support the marketing submission for an AI-enabled device reflects the agency’s total product lifecycle, ...

In the rapidly evolving landscape of healthcare technology, the integration of sophisticated healthtech devices has become indispensable. As the CEO of a company focused on providing advanced device ...

With more than 700 networked AV products, device management and monitoring requirements were paramount. When you purchase through links on our site, we may earn an affiliate commission. Here’s how it ...

Get the latest federal technology news delivered to your inbox. In the wrong hands, a government-issued mobile device poses a serious cybersecurity threat. Troublingly, a July 2023 report revealed ...

Since its introduction in 2021, Apple has always seen Declarative Device Management (DDM) as the future for device management on its platforms. At this year’s WWDC, it told us that future has arrived, ...

Kandji has announced several new innovations to its Device Harmony platform. These new features aim to help businesses keep their Apple devices secure and productive, making it easier for them to ...

Increased R&D investments to integrate AI on devices across disease states designed to boost productivity, efficiency, and diagnostic confidence for healthcare professionals, and drive the company’s ...

An artificial intelligence (AI)–enabled handheld elastic scattering spectroscopy (ESS) device improved the sensitivity for skin cancer diagnosis and management by primary care physicians (PCPs), with ...