October 18, 2021
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Top Story
11 companies, including Quidel and Becton Dickinson, were chosen by the NIH to receive a total of $77.7 million in funding to develop and produce 12 fast COVID-19 diagnostic tests under the Rapid Acceleration of Diagnostics initiative. RADx did not specify how much each company will receive.
Full Story: 360Dx (tiered subscription model) (10/14) 
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Business & Market Trends
Bob Ragusa has been chosen to serve as CEO of Grail, which operates as an independent unit of Illumina. Ragusa has previously served as executive vice president of engineering and global operations at Accuray.
Full Story: Seeking Alpha (free registration) (10/15) 
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John Soloninka has been chosen to serve as chief operating officer of SpinaFX Medical. Soloninka previously co-founded an AI-based oncology management company later purchased by Varian Medical Systems, as well as a cloud-based medical imaging company that was purchased by Merge Technologies.
Full Story: MassDevice (Boston) (10/15) 
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Science & Health
Scientists from Pennsylvania State University are working on a low-cost, skin-adhered sensor that can track blood glucose levels using the user's sweat.
Full Story: New Atlas (10/15) 
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An exoskeleton that could help above-knee amputees walk has been developed by researchers from the University of Utah. "We're very close to what an average person would expend at the same speed. The metabolic consumption is almost indistinguishable from that of an able-bodied person, depending on the fitness level," said Tommaso Lenzi, one of the researchers.
Full Story: MedGadget (10/14) 
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Patients with type 2 diabetes reduced their blood glucose levels and adhered to medication regimens after pharmacists at St. Joseph's/Candler Health System began using audio-only telehealth and remote patient monitoring services, according to a report in the Journal of the American Pharmacists Association. A greater percentage of patients met the Merit-based Incentive Payment System standard of an A1C lower than 9% after the telehealth and RPM program was implemented, according to the report.
Full Story: mHealth Intelligence (10/14) 
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Emerging Technologies
The IntelliSite digital pathology platform has been launched by Royal Philips. The platform includes a suite of scalable software tools that can help increase the efficiency of pathology laboratories, facilitate collaboration, improve diagnostic confidence, streamline workflows and integrate artificial intelligence.
Full Story: MobiHealthNews (10/15) 
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Hot Topics
Government & Regulatory
President Joe Biden is considering nominating Robert Califf, M.D., as the new FDA commissioner, but he has yet to make a final decision, according to multiple sources. Califf held the same role for one year during the Obama administration.
Full Story: The Washington Post (tiered subscription model) (10/14) 
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The FDA has given emergency use authorization to Xtrava Health for its SPERA COVID-19 Ag Test for SARS-CoV-2. The test can be used by CLIA-certified labs to perform moderate, high or waived-complexity tests.
Full Story: 360Dx (tiered subscription model) (10/15) 
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An emergency use authorization application has been submitted by LumiraDx to the FDA for its LumiraDx SARS-CoV-2 & Flu A/B Test.
Full Story: Seeking Alpha (free registration) (10/15) 
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AdvaMed Events and Education
October 26, 2021
AdvaMed Advance will hold its annual I&D Summit to facilitate industry-wide progress on recruiting and retaining innovative talent. We invite all AdvaMed members to learn from industry peers as well as share your own perspective on how your organization is building a positive, accountable workplace culture. The I&D Summit will feature a live discussion about recruitment and retainment best practices led by Dr. Stefanie K. Johnson, Associate Professor of Management at CU Boulder's Leeds School of Business and a subject matter expert on diversity, equity, inclusion and belonging. During the session, attendees will be invited to join smaller breakout groups for deep dives into the core topics. This event will be held virtually and is free to attend for AdvaMed members. Register for this year's I&D Summit.
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December 6 - December 7, 2021
This December, AdvaMed is bringing together experts across the device security spectrum for the Cybersecurity Summit. Experts will provide in-depth and timely updates on the state of medical device cybersecurity, including issues related to FDA requirements, cybersecurity during and after the COVID-19 pandemic and cybersecurity management practices. This year's Cybersecurity Summit will be held virtually. Sign up to receive updates about registration, speakers and more!
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