Insights

Thought Leadership on SaMD, DTx & Connected Device Systems

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Article

2023 Is the Tipping Point for Bluetooth 5 in Connected Medical Devices

bluetooth, SaMD

ScientiaMobile and Orthogonal Release Data Analysis Showing Bluetooth 5’s Tipping Point Will Come in 2023; Medical Device Manufacturers Need to Act Now to Be Ready Medical device manufacturers will be able to engineer most of their consumer-facing products for the US market to use the Bluetooth 5.x standard by 2023, without having to invest resources […]

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Article

FDA Software Precertification: A Working Guide for Medical Device Companies 

FDA, SaMD

Recent years, we have seen digital health technologies moving toward rapid adoption in the United States. Yet, Software as a Medical Device (SaMD), mobile medical devices, digital therapeutics (DTx), and Device manufacturers with artificial intelligence (AI) components are often anxious about the lengthy and detailed process of the existing FDA’s premarket review for medical devices. […]

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