FDA issues EUA for Truvian COVID-19 test

From Medical Design & Outsourcing

• Exceeding regulatory requirements: Beyond the checklist
  Many manufacturers run into issues as they adjust their devices and testing plans to meet updated regulatory requirements. Using a risk-based approach to predict and mitigate risks can help prevent costly setbacks. Sherry Parker, WuXi AppTec Between the EU Medical Device Regulation (MDR) delay and other regulatory bodies shifting priorities due to COVID-19, manufacturers are… […]
• FDA medical device user fees to increase 7% in 2021
  By Stewart Eisenhart, Emergo Group The US Food and Drug Administration plans a 7% medical device user fee increases for the 2021 fiscal year, raising costs slightly for premarket submissions including 510(k) Premarket Notifications, Premarket Authorizations (PMA) and De Novo requests for classification. Get the full story here at the Emergo Group’s blog. The opinions… […]
• MedAcuity advising Ventilator Project on software
  MedAcuity Software (Westford, Mass.) announced today that it has volunteered to provide technical software assessment for The Ventilator Project, a non-profit working on developing a low-cost ventilator specifically for COVID-19 patients. Founded in March 2020 by entrepreneur Tyler Mantel of Watertower Robotics, The Ventilator Project has built a team of more than 250 volunteers from… […]
• Hologic applies for pooled COVID-19 testing nod
  Hologic (NSDQ:HOLX) announced today that it has self-validated use of its Aptima and Panther Fusion molecular diagnostic COVID-19 assays with pooled patient samples and applied for an FDA emergency use authorization (EUA) for pooled testing. Marlborough, Mass.-based Hologic is the third major company to announce it is seeking such authorization. Quest Diagnostics (NYSE:DGX) gained a pooled-sample testing EUA in July,… […]
• Canon Medical launches mobile digital X-ray platform
  Canon Medical Systems USA announced that it has launched a mobile digital X-ray system designed to streamline bedside exams to help improve workflow and productivity. The FDA 510(k)-cleared Soltus 500 has a compact design with features that promote efficiency and patient safety, without compromising image quality. They include: Intuitive tubehead controls, including an 8.4-in. touchscreen… […]
• Electronic Valve Technology
  The following is an overview of different technologies available when selecting the correct electronic valve for your application. Spider Valve Technology Invented and patented by Clippard, this deceptively simple design features only one moving part with a mere 0.007″ of travel. The spider is an armature spring that undergoes a variety of proprietary processes, including… […]
• FDA opens umbrella authorization for surgical masks
  Faced with a growing number of coronavirus cases and a shortage of personal protective equipment (PPE), the FDA has extended emergency use authorizations (EUAs) to certain surgical masks that are not protective against small airborne particles. Unlike N95 and some KN95 respirators, these masks “may be effective in blocking splashes and large particle droplets,” the… […]
• Medtech and COVID-19: 7 things you need to know
  When COVID-19 set upon the U.S. in March, medtech executives only had a month at most to explain to analysts in quarterly calls how the pandemic was hitting their companies — not nearly enough time to understand the long-term impact. Three more months have passed since those quarterly calls, and we’re now wrapping up a… […]
• Report: Will Dr. Hahn crack under political pressure?
  Many jobs have come with increased stress levels during the coronavirus pandemic, from ICU staff to Walmart greeters. Now officials who’ve been keeping tabs on FDA commissioner Dr. Stephen Hahn are wondering whether he can weather the strain of defending science while working for the Trump administration, according to a New York Times report. Hahn… […]
• Hologic spending more than $50M to expand COVID-19 test production
  Hologic (NSDQ:HOLX) is spending $50 million — including $14 million during its most recent quarter — to boost its production of COVID-19 tests. The U.S. government is providing $7.6 million to support the effort. Hologic’s business partner Stratec is also doubling the production of the Panther instruments that run Hologic assays. Get the full story on our sister site… […]
• DTW Podcast: 10 ways medtech is finding its footing amid COVID-19
  When COVID-19 set upon the U.S. in March, medtech executives had a month at most to tell Wall Street analysts how the pandemic had hit the industry’s largest companies. We heard about short-term hits in revenues, procedures and employee headcounts, but uncertainty clearly ruled the day. Over the past few weeks, medtech executives from several… […]