As we enter a new year, Innovenn is looking ahead to our second decade, and excited about the innovations and future paths of health advancement. The next ten years hold tremendous potential to revolutionize the life sciences industry, and we are committed to driving achievements that redefine health and wellness for individuals worldwide. Precision medicine […]
As we approach the close of another year, it’s a moment for reflection, celebration, and anticipation for what’s to come. For us, this year carries a special significance—it marks the conclusion of 10 incredible years of innovation, collaboration, and growth. In this past decade, we have witnessed significant advancements in the medical device, Software as […]
Is your product really a SaMD? The Food and Drug Administration (FDA) and the European Medicines Agency (EMA) present similar, but slightly different, definitions for Software as a Medical Device (SaMD). It’s important to understand if your product’s intended purpose (or intended use) falls within or outside of the scope of SaMD in each respective […]
The Rise and Importance of Digital Health The FDA has established classifications for approximately 1,700 different generic types of devices, where they are regulated to different degrees based on the level of control necessary to assure the safety and effectiveness of the device1. With the various kinds of digital health products, it can be confusing […]
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