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Can Connected Wearable Medical Devices Improve Healthcare?
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Opportunities abound for wearable medical devices that enable real-time patient monitoring as well as management of chronic health conditions.
Guardant Hits Milestone with FDA Nod for Liquid Biopsy Test
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In addition to receiving FDA approval for its liquid biopsy test, the Redwood City, CA-based company said it recently filed for emergency use authorization for a COVID-19 test.
Siemens Healthineers Changes Antibody Testing Conversation with New EUA
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The Erlangen, Germany-based company has won the designation for semi-quantitative Sars-CoV-2 IgG antibody tests. The tests estimate the quantity of a patient’s antibodies produced against ...
Another COVID-19 Antibody Test Bites the Dust
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FDA has revoked a previously-issued emergency use authorization for another COVID-19 antibody test.
Complying with ISO 14971:2019
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Separate risk management and FMEA for better medical device development.
Strategies to Prevent Component Shortages During a Crisis
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After years of economic expansion and a solid start to 2020, manufacturers found themselves suddenly, early in the year, in the middle of a global crisis with COVID-19. Its effects on manufacturing ...
Developing a Rapid Sars-Cov-2 Antibody Test
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Research behind the test was published in the journal Vaccines on July 15, 2020.
Ensure Success Throughout the Entire Medical Device Lifecycle
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Medical device experts advise focusing on quality at every stage.
Stryker Beats Consensus but Still Feels COVID-19 Sting
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The Kalamazoo, MI-based company said net sales of $2.8 billion decreased 24.3% in the quarter.
4 Deals Stopped by COVID-19 and 4 That Kept Going Despite the Virus
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Here are four deals that were successful and four deals that didn’t turn out so well during the pandemic.
Boston Scientific Reports Encouraging Sales Trends in July
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Despite the procedure volume impact from COVID-19, Boston Scientific shared an upbeat outlook on the rest of the year.
A Tale of Two Pandemics: How Companies Are Succeeding—or Struggling—with Work-at-Home Teams
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Preparation has helped companies remain productive as employees switched to working from home during the pandemic. But what can a company do if it hadn’t prepared?
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