July 30, 2021
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Top Story
Smith & Nephew generated $1.3 billion in revenue during its second quarter, up 48.2% from the previous year.
Full Story: Becker's Spine Review (7/29) 
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Business & Market Trends
Dexcom generated $595.1 in sales and $62.9 million in profits during its second quarter, which ended June 30.
Full Story: Drug Delivery Business News (7/29) 
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Exo, a startup that developed a handheld ultrasound device and a platform to support it, raised $200 million in its Series C funding round. Most of the new capital will toward commercializing the device.
Full Story: TechCrunch (tiered subscription model) (7/29) 
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Science & Health
Ultrasound assists in diagnosis of Olympic injuries
Ultrasound and other imaging methods are being used to diagnose athletes' injuries at the Tokyo Olympics. For example, one New Zealand athlete underwent an ultrasound during a pre-Olympic soccer match.
Full Story: AuntMinnie (free registration) (7/29) 
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Digital Transformation in Medical Device
Sponsored content from Kalypso
Four Key Questions to Ask Before Implementing Data Quality Software
Before you embark on the search for data quality software, ensure you are set up for success by asking these four questions.
Emerging Technologies
The Jot Dx insertable cardiac monitor, which may help remotely identify cardiac arrhythmia and improve diagnosis accuracy, has been released by Abbott.
Full Story: Medical Device Network (UK) (7/30) 
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Government & Regulatory
European regulators have given CE mark certification to MeMed for its MeMed COVID-19 Severity tool that could help determine the risk of severe outcomes in people.
Full Story: Medical Device Network (UK) (7/28) 
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The FDA has given breakthrough status designation to Biofourmis for its BiovitalsHF medical device software that is used to treat heart failure.
Full Story: FDAnews (7/30) 
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The FDA has given 510(k) clearance to NYU Langone Health for its Genome PACT genetic test for solid tumors.
Full Story: GenomeWeb Daily News (free registration) (7/29) 
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European regulators have given CE-IVD mark certification to Cepheid for two PCR-based tests that detect HIV-1, its Xpert HIV-1 Qual XC and its Xpert HIV-1 Viral Load XC.
Full Story: 360Dx (tiered subscription model) (7/29) 
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Health Canada has given its approval to Luxsonic for its SieVRt, a software that would allow radiologists to use a virtual reality headset to diagnose patients remotely.
Full Story: FDAnews (7/30) 
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AdvaMed Events and Education
Join us for a timely webinar focused on the FDA Breakthrough Devices Program and best practices for participation. Hosted by AdvaMed, this webinar will feature presentations from key FDA and CMS staff, followed by an engaging roundtable discussion and Q&A with FDA, CMS and industry. Webinar attendees will have the opportunity to submit questions upon registration or during the webinar. Registration for the webinar is free for AdvaMed members and government employees. Learn more.
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The MedTech Conference, powered by AdvaMed, will host its trademark award-winning programming and networking opportunities in a new hybrid structure, combining the benefits of both in-person and virtual events, on September 27-30. Attendees can participate in The MedTech Conference in a fully virtual environment, and they can also take advantage of limited-capacity in-person gatherings in Washington, D.C., and in Minneapolis, Minnesota. For more information on The MedTech Conference 2021, visit the FAQs page, which will continue to be updated over the coming months.
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It is a time in which we will redefine what it means to be human, for this is not just the start of a revolution, it is the start of an evolution.
David A. Sinclair,
biologist, professor of genetics
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