GENETWORx Labs launches test for Covid-19, flu, and RSV detection
GENETWORx Labs has launched a new diagnostic Flu A-B/Covid-19/RSV combination test that helps in early detection of all three separate…
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One thing to not be thankful for – even more Covid-19
As Thanksgiving wraps up in the US, Americans may find something that brings little gratitude: even more Covid-19. 2020 has…
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GENETWORx Labs launches test for Covid-19, flu, and RSV detection
GENETWORx Labs has launched a new diagnostic Flu A-B/Covid-19/RSV combination test that helps in early detection of all three separate respiratory viruses in patients with…
Lighthouse Lab in UK begins processing of Covid-19 tests
The Lighthouse Lab in Charnwood, Loughborough, UK, has initiated Covid-19 testing sample processing using PerkinElmer solutions as part of its partnership with the Department of…
Swiss firm Abionic unveils new test to assess Covid-19 severity
Swiss company Abionic has launched the new tool, Covid Sequential Organ Failure Assessment (cSOFA) score, which can evaluate the severity…
FDA grants EUA for RapidRona’s self-collection Covid-19 kit
Medical device company RapidRona has received emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for its…
GE Healthcare launches AI algorithm for Covid-19 patients’ ETT placements
GE Healthcare has unveiled a new X-ray artificial intelligence (AI) algorithm that can aid clinicians in assessing Endotracheal Tube (ETT)…
Beckman Coulter introduces semi-quantitative antibody test for Covid-19
Clinical diagnostics firm Beckman Coulter has launched its semi-quantitative assay, Access SARS-CoV-2 IgG II, which can measure a patient’s relative…
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FDA grants EUA for RapidRona’s self-collection Covid-19 kit
Medical device company RapidRona has received emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for its…
GE Healthcare launches AI algorithm for Covid-19 patients’ ETT placements
GE Healthcare has unveiled a new X-ray artificial intelligence (AI) algorithm that can aid clinicians in assessing Endotracheal Tube (ETT)…
Company Tailored MDR / IVDR Gap-Assessment
You do not have the time or resources to prepare a gap-assessment over your company and products? No problem. We…
MDSAP vs ISO 13485:2016 Checklist
The MDSAP vs. ISO 13485:2016 checklist supports you in assessing all requirements and help to track those during the implementation…
Regulatory Intelligence Paper
Remain informed about upcoming rules, regulations, guidance, and standards. According to the new MDR, IVDR, and ISO 13485:2016, it is…
IVDR GAP-Assessment Tool
Our IVDR gap assessment tool is our basic version. This tool contains complete IVDR with all chapters (1 - 10)…