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Regulatory FDA seeks more power for medical device cybersecurity mandates FDA is seeking “additional legislative authorities” meant to bolster medical device cybersecurity amid [...]

Regulatory US FDA rolls out final guidance on Unique Device Identifier (UDI) labeling requirements The FDA has published its long-awaited final guidance on form and content requirements for [...]

Regulatory Device, digital health firms oppose HHS’ proposed 510(k) exemptions  Medical device and digital health companies have largely come out in opposition to a proposal from the Department [...]

Regulatory UK passes post-Brexit medical device regulatory bill into law The cornerstone of the UK’s post-Brexit medical device regulatory system, the Medicines and Medical Devices Act 2021, [...]

Researchers and engineers with great ideas sometimes need help getting their innovations from the concept stage to being a fully marketed product, and that’s where Lebanon’s Simbex comes into [...]

A Technology Review often begins with early assessment of the technology solution, which entails confirming that the technology is feasible and has not already been developed.