Software as a Medical Device
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The "Future of AI-Powered Healthcare" meetup explored how AI is transforming women's health by improving diagnostics, treatment options, and addressing care disparities. Cindy, Garima Gale, Shazia Akbar, and Emma Tolstorf shared insights on advancements in personalized medicine, focusing on fertility, hormonal tracking, and pelvic health, with companies like Future Fertility, Juniper Genomics and Eli Health leading the way. Emphasizing the importance of creating data sets tailored to women's unique physiological needs, the session also highlighted strategies for ensuring equitable access to AI-powered healthcare. This includes leveraging existing hardware like smartphones and partnering with enterprises to provide personalized care solutions that are accessible and practical for all women.
At our third Software as a Medical Device meetup, Danielle Dorfman Faruq (Regulatory & Quality Director at Kintsugi) shared learnings and tips on how to get your SaMD in the hands of real users faster, while meeting regulatory requirements.
Motion graphics are an effective way to add visual interest to any website or app. They're also a great way to highlight key points in your content and improve patient compliance. We've put together examples of how motion graphics can be used effectively in digital therapeutics.
Last week at our second SaMD meetup, we discussed how to apply agile product management strategies to building and validating digital therapeutics.
SaMD Primer
Learn more about SaMD and how it will change the future of healthcare.
Foundations
Software as a medical device (SaMD) represents an opportunity to successfully build and launch patient-centric digital health products and platforms. In this article, we'll take you through the fundamentals: what is (and isn't) a SaMD, how federal and international agencies classify and regulate SaMD, and how you can get your digital health product to market faster.
At our third Software as a Medical Device meetup, Danielle Dorfman Faruq (Regulatory & Quality Director at Kintsugi) shared learnings and tips on how to get your SaMD in the hands of real users faster, while meeting regulatory requirements.
Last week at our second SaMD meetup, we discussed how to apply agile product management strategies to building and validating digital therapeutics.
World's first Javascript React Native app with CE marking as a class II SaMD
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