The Food and Drug Administration today released two guidance documents; one related to low-risk wellness products (including ...

Software in the healthcare industry has come a long way over the past 20 years. Medical device companies, like most life sciences companies, were a bit hesitant to incorporate software and automation ...

Computer software used in healthcare device applications developed for demographic data gathering, physical examinations or therapies are increasingly part of the regulatory landscape. This article, ...

New Delhi: In a move to align India’s regulatory framework for medical device software with global standards, the Central Drugs Standard Control Organization (CDSCO) has released new draft guidelines ...

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 ...

FDA has an impressive collection of ongoing digital health initiatives, and the regulation of software and hardware has evolved greatly since smartphones and tablets were launched about a decade ago.