This article is authored by Dr Ashok Kumar Moharana, chief medical officer, Healthium Medtech Ltd.

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 ...

Technology enables us to do wonderful things. The PCs and mobile devices at the center of our digital world are an indispensable part of our personal and working lives. They offer us a gateway to ...

The landscape of IoT devices is transforming, marked by a fundamental evolution toward software-driven innovation. In this era, the paradigm of Software-Defined IoT devices is redefining traditional ...

Software-based medical devices are integral to healthcare. To enter the marketplace, a company must successfully navigate and comply with applicable national and international regulatory requirements.

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 ...

Medical device manufacturers are increasingly implementing integrated mobile software and device applications to automate the inventory management process. By doing so, companies can better track ...

India’s drug regulator CDSCO has issued final guidance on medical device software under MDR-2017, clarifying SaMD vs SiMD rules, Algorithm Change Protocol for AI updates, and licensing processes. The ...

The US Food and Drug Administration (FDA) has released draft guidance for sponsors outlining its thinking about the documentation needed to support the agency’s evaluation of device software functions ...

Apple will soon release new operating systems for all of its devices, causing some older gadgets to fall out of software support in 2026. Here is the list.