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Software Precertification Pre News Today : Breaking News, Live Updates & Top Stories | Vimarsana

Generative AI For Mental Health Is Upping The Ante By Going Multi-Modal, Embracing E-Wearables, And A Whole Lot More

On my continuing coverage of generative AI used for mental health, I take a look at the latest trends and what is coming down the pike. Get ready for what will happen.

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Navigating the Regulatory Landscape: FDA Approval and Patent Protection for Software as a Medical Device | Knobbe Martens

Software is increasingly used as a medical device, transforming the healthcare industry with the goal of improving patient outcomes. However, developing software as a medical device.

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Digital Health: Significant FDA Policy Developments In 2022 - Healthcare

In 2022, FDA retreated from a flexible approach to its regulation of digital health in two key areas: (1) its PreCertification Program for software as a medical device (SaMD) and (2) its guidance.

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FDA s Latest Twist on Digital Health Oversight Brings Big Shift | Cooley LLP

Facing novel, swiftly evolving technologies in the digital health space, the US Food and Drug Administration has been trying to balance fostering innovation with providing reasonable.

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FDA Vs Congress The Software Showdown

September 2022 will be remembered as a seminal turning point in digital health in the U.S. With the FDA’s final guidance on Clinical.

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