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Med Device Online - March 10, 2021
The pandemic year of 2020 presented FDA with many enormous challenges, including how to use emergency authorizations to approve diagnostic tests, personal protective equipment, and therapies, how to conduct remote inspections, and what accommodations should be made for clinical trials disrupted by COVID-19. On top of that, FDA found itself facing an enormous and unprecedented amount of political pressure, with its actions, or lack thereof, potentially altering the presidential election. Yet through it all, the agency continued to largely fulfill its core responsibilities of ensuring compliance and helping to bring new products to market, including, for example, approving by its own reckoning 132 novel medical devices, a significant increase over 2019. Now that we are in 2021, what big developments can we expect from FDA in general and regarding medical devices in particular? This article explores some of the FDA initiatives and activities worth fol
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Google Cloud announced this week that its Healthcare Consent Management API, aimed at giving users a simple way to manage individuals consent over health data use, is now generally available.
The API was made available via Public Preview last fall. According to the tech giant, early adopters have used it to create personalized patient portals, securely integrate data into clinical workflows and develop virtual clinical trials. We’re pleased to add the Healthcare Consent Management API to our portfolio of solutions, and to support healthcare and life sciences professionals as healthcare data begins to span a variety of devices, scenarios, and locations, wrote Google Cloud Healthcare and Life Sciences Product Manager Jameson Rogers in a blog post.
Monogram Health and Cigna Launch National Kidney Care Management Program
Program Now Covers 18 States Where Cigna Individual MA Customers Live
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NASHVILLE, Tenn., March 10, 2021 /PRNewswire/ Monogram Health announced today that it has expanded its in-home kidney care management program to Cigna Medicare Advantage customers in 11 new states, providing convenient, personalized care to help people manage chronic kidney disease (CKD) and End Stage Renal Disease (ESRD).
The program is now available to Cigna s individual MA customers in most of Florida as well as Texas, Pennsylvania, Illinois, North Carolina, South Carolina, New Jersey, Delaware, Maryland, Missouri, Kansas, and Colorado and the District of Columbia. It was previously available to individual MA customers in Arkansas, Arizona, Alabama/North Florida, Mississippi, Tennessee and Georgia.