Diagnostics
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Chronic Disease | Diagnostics
Diagnostic May Bring Faster, Cheaper Cancer Testing to Remote Settings
The CytoPAN is used to study breast cells gathered with fine-needle aspiration, a less invasive alternative to standard biopsies.American Association for the Advancement of Science 08.07.20
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Diagnostics
RadNet, Hologic Collaborate on AI for Breast Health
Collaboration will include data sharing, R&D, and an upgrade of RadNet’s fleet of Hologic mammography systems to state-of-the-art imaging technology.Hologic Inc. 08.07.20
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Diagnostics
Roche Nabs FDA Authorization for First Epstein-Barr Virus Quantitative Test
Virus's DNA levels are associated with a range of life-threatening diseases, including cancer in transplant patients.Roche 08.07.20
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Chronic Disease | Diagnostics | Software & IT
Eyenuk's Autonomous AI for Diabetic Retinopathy Screening Wins FDA Nod
First FDA cleared AI technology for autonomous detection of both more than mild and vision-threatening diabetic retinopathy.Business Wire 08.07.20
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Diagnostics
FDA OKs Siemens Healthineers' SOMATOM On.site for Bedside CT Head Scans
Mobile CT scanner reimagines head imaging of critically ill patients by enabling patients and staff to remain in ICU.Business Wire 08.07.20
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Diagnostics
Vela Diagnostics' Coronavirus PCR Test Earns EUA
The probe-based reverse transcription PCR test detects SARS-CoV-2.PR Newswire 08.07.20
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Diagnostics
Siemens Healthineers Obtains EUA for Semi-Quantitative Antibody Test
The SARS-CoV-2 IgG Antibody Test offers the first EUA for a semi-quantitative assay to help clinicians assess the level of an individual‘s immune response.Business Wire 08.05.20
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Chronic Disease | Diagnostics
Scientists Suggest Device to Make Breast MRI More Effective
A group of Russian scientists, including ITMO University researchers, has proposed a system that can be used to update existing MRI scanners.ITMO University 08.05.20
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Diagnostics
Fujirebio Diagnostics Initiates Testing of Fully Automated COVID Antigen Assay
The Lumipulse SARS-CoV-2 Antigen assay will be available for use on the LUMIPULSE G1200 instrument.Business Wire 08.05.20
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Diagnostics
Finger-Prick Blood Analyzer Company Raises $71M
Sight Diagnostics will use funding for the global expansion of its FDA 510(k) cleared, CE marked device.Business Wire 08.05.20
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Diagnostics
Clinical Reference Laboratory Earns EUA for Self-Collected COVID-19 Saliva Test
Shown in CRL's EUA studies to be more sensitive and accurate than the standard COVID-19 anterior nasal swab test.PR Newswire 08.03.20
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Diagnostics
Precipio Releases COVID-19 Antibody Test
Tests will be initially rolled out as a CLIA test run in Precipio's lab.GlobeNewswire 07.31.20
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Diagnostics
FDA Authorizes New Quest Lab Technique to Boost COVID-19 Testing Capacity
Speeds the process of extracting viral RNA from specimens.PR Newswire 07.31.20
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Diagnostics
U.S. Government Invests in BD Veritor Solution
Supports the scale up of U.S. manufacturing of COVID-19 diagnostic tests.BD 07.31.20
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Diagnostics
ContextVision Redefines Image Enhancement for Ultrasound
Medical technology software company is driving advanced patient care with latest innovations in image enhancement.ContextVision 07.30.20
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Diagnostics
AdvaMed Creates National COVID-19 Testing Registry
Since the beginning of the pandemic, over 65 million tests have been manufactured and shipped nationwide, says AdvaMed.AdvaMed 07.29.20
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Diagnostics
Truvian's Easy Check COVID-19 IgM/IgG Test Gains EUA
The test is being produced at mass scale at a U.S.-based manufacturing facility.PR Newswire 07.29.20
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Diagnostics
Color Earns EUA for Unmonitored COVID-19 Testing
Alleviates demand on healthcare workers from having to administer test samples.PR Newswire 07.28.20
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Diagnostics | Software & IT
FDA Clears Zebra Medical's HealthMammo AI to Spot Suspicious Mammograms
Zebra Medical is now the first AI startup with six FDA clearances across three different modalities.Business Wire 07.27.20
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Diagnostics
FDA Authorizes First COVID-19 Test to Screen Asymptomatic People
LabCorp COVID-19 RT-PCR Test EUA reissued for asymptomatic cases, test pooling.U.S. Food and Drug Administration 07.27.20
