A crisis is worsened when the lessons from it are not applied to tackling the next one – or better yet, preventing it entirely.
And preventing the next one – or at least keeping it at bay – is the idea behind a plan...
The Time Is Now: Paper Argues US Needs National Diagnostics Plan Before The Next Pandemic
Public-Private Partnerships Key
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The US needs a comprehensive plan to meet the country's testing needs in the earliest stages of an infectious disease crisis, according to a paper posted by the John Hopkins Center for Health Security. The authors of the paper say government and industry collaboration is essential in creating such a plan and urge both sectors to act now.
Keep up with the top medtech business and regulatory news.
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The US FDA has published a trio of draft guidance documents for its Assessment Scheme for Conformity Program, which began as a pilot in September 2020 to capitalize on the role of standards in the regulation of medical devices.
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Biopharmaceutical giant AstraZeneca has partnered with start-up “unicorn” Owkin to develop an AI-powered tool to prescreen for gBRCA mutations on the basis of morphological features in digitized pathology slides. Built on extensive, high-quality data sourced from the France-based PortrAIt consortium, the AI will help to prioritize patients for further testing, streamlining the diagnostic process, Owkin says.
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TRiCares announced first implantation of the Topaz transfemoral tricuspid heart valve replacement system as part of the company’s EU pivotal study. If all goes to plan, the device will compete with Edwards’ Evoque system. The announcement follows the company’s $50m series D funding raise in July.