Nov. 2 - Hologic wins $119M to help double its US coronavirus diagnostic production | Gauss claims at-home COVID-19 antigen test on par with PCR

Gauss says at-home COVID-19 antigen test comparable to PCR in clinical study; Duke researchers pitch CDS tool to keep electives going during COVID-19 surges; Siemens Healthineers projects up to 8% revenue growth in FY2021; Medtech Q3 results signal diagnostics boom, mixed bag on device growth View online | Signup | Forward

Daily Dive Nov.​ 2,​ 2020 | Today's news and insights for medtech leaders   BROUGHT TO YOU BY — American Medical Association AMA CPT®: Coding That Moves Medicine Medicine evolves with clinical innovations. Stakeholders may need a new or updated CPT code to describe their innovation. Learn more.   Hologic wins $119M from HHS, DOD to help double COVID-19 test production The medtech will make 13 million diagnostics a month in the U.S. by January 2022. Separately, InBios International scored $12.7 million to expand rapid point-of-care antigen and antibody test manufacturing. Gauss says at-home COVID-19 antigen test comparable to PCR in clinical study The company has yet to apply for FDA emergency use authorization after a 159-participant study. Such tests may "hold immense power," said Harvard epidemiologist Michael Mina, also warning EUAs are "not exactly a high bar."   Duke researchers pitch CDS tool to keep electives going during COVID-19 surges JAMA Network Open authors found that using predictive modeling to develop a clinical decision support tool could help determine patient length of stay and use of a ventilator in procedures like knee and hip replacements. Sponsored Content by Sartorius Are you GLP/GMP compliant when it comes to pipetting? Practical guide – pipetting guidelines to ensure compliance with GLP and GMP. Download now! Siemens Healthineers projects up to 8% revenue growth in FY2021 The German imaging and diagnostics giant said it won U.S. antitrust approval for its planned $16.4 billion buyout of radiation oncology specialist Varian in late October, helping the deal close in the first half of 2021. Medtech Q3 results signal diagnostics boom, mixed bag on device growth Hologic, BD and Zimmer Biomet are among the medtechs set to add to the growing mass of late summer data points this week. Read more news Featured Resources FROM: Regulatory Affairs Professionals Society RAPS Regulatory Resources for EU MDR The EU MDR Guidebook is a must-have reference tool for anyone involved in ensuring compliance with the new regulation Expand your knowledge of the EU regulatory landscape with Fundamentals of EU Regulatory Affairs, Ninth Edition Learn to successfully navigate regulatory from the new edition of Global Medical Device Regulatory Strategy What We're Reading STAT HHS relaxed oversight of problematic Covid-19 tests despite being told of accuracy concerns FierceBiotech PerkinElmer snaps up CRISPR provider Horizon Discovery in $383M deal Medtech Insight As Expected, FDA Misses Fourth Consecutive Deadline For Releasing Draft QSR The Washington Post Artificial intelligence and covid-19: Can the machines save us? Suggest a story we should read Dive Into a Topic Medical Devices Policy & Regulation Clinical Trials Manufacturing Legal M&A Research Diagnostics Digital Health Imaging Share MedTech Dive: Daily Dive with others and get rewarded. You've referred 0 readers. To become an official Dive Insider, just successfully refer 10 contacts to MedTech Dive: Daily Dive. Here's your link to share: https://www.medtechdive.com/signup/insiders/?signup_referred_by=5f93078d7aa51972095c9316

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