The FDA recently released six guidance documents as part of the agency’s continued focus on updating the regulatory stance on software as a medical device and other digital health products. The ...

Dublin, Sept. 24, 2025 (GLOBE NEWSWIRE) -- The "Market Authorisation of Software as a Medical Device (SaMD) and Medical Device Software (MDSW) Training Course (Nov 10th - Nov 11th, 2025)" training has ...

As is already the case under the current EU Medical Device Directive 93/42/EEC (as amended by Directive 2007/47/EC – “MDD”), the purpose for which the software is intended to be used is and remains ...

Until recently, safety regulations for medical device software, at least formally, were not exceptionally rigorous across the board. In addition, software was not formally classified as a medical ...

A Rochelle Park-based company has a new name it hopes will more smartly reflect its misson. A Rochelle Park-based company has a new name it hopes will more smartly reflect its misson. Sterling Tech ...

Samsung November updates arrive on the Galaxy S25 down through the Galaxy S22. The update provides the latest Android ...

One of the more mysterious aspects of using multiple Apple devices comes when you connect an iPhone, iPad, or iPod touch to a Mac and are greeted with a dialog from an app called MobileDeviceUpdater ...

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, ...