The software supply chain is critical to ensuring a secure medical device that can prevent injury, according to Gregg Van Citters, MS, PhD, a principal software quality engineering consultant at ...

In medical-device software, an update isn’t just a new feature — it can directly affect patient safety. Every code change in a surgical-laser system must be fully traceable to its verification and ...

Demystifying software updates and upgradesHow would you define a medical equipment software update? How about a software upgrade? Answering these questions isn’t so simple – it’s difficult to define ...

South Korean medical imaging company Medical IP has obtained a United States Food and Drug Administration 510(k) clearance for its AI-powered body composition analysis software. According to the ...

“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 ...

Medatixx, a German medical software vendor whose products are used in over 21,000 health institutions, urges customers to change their application passwords following a ransomware attack that has ...