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AI/ML Regulatory Masterclass from Orthogonal, UCLA Biodesign and HealthXL

AI & machine learning, FDA

Event Description: For over 10 years, Artificial Intelligence (AI) and Machine Learning (ML) have been radically impacting every industry. Yet it still sometimes seems like it should be so difficult to bring AI and ML to market as a component of FDA-regulated medical devices. Given how deep AI has penetrated into many other industries outside […]

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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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Article

When Should Your Connected Medical Device Support Bluetooth 5.0?

bluetooth, FDA, SaMD

Bluetooth 5.0 introduces a number of upgrades in speed, security and range to previous versions of Bluetooth. Yet many consumers still don’t have Bluetooth 5.0 compatible smartphones.  In this article, we take a closer look at Bluetooth 5.0 support across today’s most popular mobile devices (Apple and Android), and offer those in the medical device […]

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Article

Cloud Computing in Medical Devices: Safe, Compliant, Effective. How?

cloud, FDA, medical device software development

The cloud is eating the world, including medical devices. As of early 2020, worldwide cloud infrastructure service revenue was over $96 billion, with the combined market share of the three largest vendors, Amazon, Microsoft, and Google, at approximately 60%.  Cloud revenues of these three vendors have grown by over 50% per year since 2013. Part […]

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Article

Agile in an FDA Regulated Environment

agile, FDA

How do you get the benefits of agile while maintaining quality and regulatory compliance?

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Article

Four Success Factors for Accelerating Digital Health Solutions

digital health, FDA, SaMD

Executive Summary This is the fourth and final blog in our late spring/early summer series titled “Sinking, Swimming, or Surfing: COVID-19 and The Great Acceleration of Digital Health.” In this article, we discuss four critical success factors for digital health solutions. Success Factor #1—Don’t get stuck in Flatland: Think in terms of “And,” not “Or.” […]

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