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September 27, 2023
On September 19, 2023, the U.S. Food and Drug Administration ("FDA" or "the Agency") published a draft guidance, Regulatory Considerations for Prescription Drug Use-Related Software (the "Guidance")...
September 27, 2023
On September 19, 2023, the U.S. Food and Drug Administration (“FDA” or “the Agency”) published a draft guidance, Regulatory Considerations for Prescription Drug Use-Related Software...
September 8, 2023
We bring you Vital Signs, a curated, one-stop resource on the most notable digital health law updates from our U.S. and global contributors. In Industry Insights...
May 10, 2023
On April 3, 2023, FDA released the draft guidance titled "Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions"...
May 4, 2023
Femtech (female health technology) has made significant progress toward bringing women’s health to the forefront of medical attention. However,...
May 4, 2023
A PCCP must be reviewed by FDA and established as part of a marketing authorization prior to a manufacturer's implementing any modifications under the PCCP.
November 22, 2022
Welcome to the first installment of Arnold & Porter's Virtual and Digital Health Digest. This inaugural edition covers September and October highlights across the virtual and digital health space.
November 15, 2022
/PRNewswire/ -- The "Global GNSS Simulators Market by Component (Software, Hardware, and Services), GNSS Receiver (GPS, Galileo, GLONASS, and BeiDou),...
August 1, 2022
Artificial intelligence innovations continue to fuel advances across diverse life science applications, including drug discovery and digital health.
March 4, 2021
Share this article Share this article ResearchAndMarkets.coms offering. This report assesses AR, MR, and other immersive technology components, the AR/MR ecosystem, and competitive landscape. The report evaluates market opportunities for hardware, software, and services. The analysis takes into consideration market drivers and constraints such as potential regulatory developments and associated implications. The report provides detailed qualitative and quantitative analysis including forecasts ...