Ghent, Belgium – 6September2023– Sequana Medical NV(Euronext Brussels: SEQUA) (the "Company" or "SequanaMedical"), a pioneer in the treatment of fluid overload in liver disease,...
Clinical investigations are defined within both FDA and EU MDR as the systematic investigation involving one or more human subjects, undertaken to collect data...
Pregnancy is an incredible and life-changing journey for women, filled with significant changes and experiences. However, this transformational process can also bring about unique...
In our fast-paced world, attaining and upholding a healthy lifestyle can often resemble interpreting an enigmatic cipher. However, the reality is that one need...
In April 2023, FDA published a new draft guidance, Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device...
Medical device security is of paramount importance in today’s interconnected healthcare landscape. The integration of internet-connected devices in medical facilities has ushered in a...
