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FDA Announces Action Plan for Oversight of AI/ML in Medical Devices | Perkins Coie

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On January 12, 2021, the U.S. Food and Drug Administration (FDA) released the Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan (Action Plan). The Action Plan expresses that the “FDA’s vision is that, with appropriately tailored total product lifecycle-based regulatory oversight, AI/ML-based Software as a Medical Device (SaMD) will deliver safe and effective software functionality that improves the quality of care that patients receive.”
The FDA currently regulates and has approved “locked” SaMD utilizing AI/ML, but has struggled to determine the appropriate regulatory approach for “adapting” AI/ML SaMD that learns and evolves using real world inputs over time. The Action Plan is the FDA’s step forward to address this challenge. ....

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Exadel Records Strong Year with Surge in Client Roster, Additions to Executive Team and Record-Breaking Company Growth

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WALNUT CREEK, Calif., Jan. 12, 2021 /PRNewswire/ Exadel (www.exadel.com), a global provider of digital engineering solutions and services, announces a successful 2020 including a burgeoning client portfolio, continued growth, including new executive team members and 2020 sales projections. This year, Exadel gained 24 new clients and many existing clients expanding into new projects. The COVID-19 pandemic created an immediacy for digitization across all industries and verticals giving Exadel an edge with its seasoned product engineering and digital transformation expertise.
We could not be prouder of the entire Exadel team for persevering and excelling during one of the toughest years imaginable, said Fima Katz, CEO and founder of Exadel. I realize our growth and success as a company in 2020 is a rarity and stands as a testament to the value we deliver to our clients. We approach everything with an Agile product engineering m ....

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