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Diagnostics
Rapid Antigen Tests Manufacturer Acquires BIOLAB
Deal will create jobs and increase Innova's U.S. COVID-19 test kit manufacturing capability.Innova Medical Group Inc. 01.14.21
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Diagnostics
PerkinElmer's SARS-CoV-2 RT-PCR Assay Earns EUA for Asymptomatic Testing
Gold-standard testing of individuals without COVID-19 symptoms key to controlling the spread.Business Wire 01.14.21
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Diagnostics
High-Volume COVID Antigen Test Receives FDA EUA
Ortho’s Vitros can run up to 130 tests per hour and helps address testing backlogs, supply shortages, and delayed results.Ortho Clinical Diagnostics 01.13.21
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Diagnostics
Researchers Develop Chip That Can Detect COVID-19 Antibodies in a Minute
New diagnostic platform could be a valuable tool for detecting exposure to multiple viruses.Bob Marcotte, University of Rochester 01.13.21
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Diagnostics
Abbott to Supply Additional 30M COVID-19 Tests to U.S. Gov't
Company is in final stages of completing its self-funded capacity expansion across U.S. manufacturing sites.PR Newswire 01.13.21
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Diagnostics
Olympus and Hitachi Sign Five-Year Contract
Will jointly develop Endoscopic Ultrasound Systems.Olympus Corporation 01.11.21
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Diagnostics
ForaCare Suisse AG Launches COVID-19 Antigen Rapid Test
Provides fast, accurate, and easy-to-interpret test results.PRNewswire 01.11.21
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Diagnostics | Neurological
FDA OKs Abbott's First-of-Its-Kind Rapid, Handheld TBI Test
Produces a result within 15 minutes after a plasma sample is inserted.Abbott Laboratories 01.11.21
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Diagnostics
SARS-CoV-2 Mutation Prompts FDA Alert
Impact remains low, but false negative results can occur with any molecular test.U.S. Food and Drug Administration 01.11.21
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Diagnostics
CareDx Partners with IDbyDNA
Will develop AlloID, a transplant patient-specific metagenomic infectious disease test platform.Globe Newswire 01.08.21
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Diagnostics
Siemens Healthineers’ Laboratory-Based IL-6 Assay Receives EUA
Helps identify severe inflammatory immune responses in patients confirmed to have COVID-19.Siemens Healthineers 01.08.21
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Diagnostics
Quantitative Transmission Ultrasound Outperforms Mammography
QT Imaging completes first-in-human study of transmission ultrasound as a new imaging technology for breast health screening.PRNewswire 01.07.21
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Diagnostics
University of Birmingham Researchers Invent New COVID-19 Test
Delivers accurate results within minutes.University of Birmingham 01.07.21
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Chronic Disease | Diagnostics
Hologic to Buy Cancer Test Maker Biotheranostics for $230M
Accelerates Hologic’s entry into the oncology growth market, provides new lab capabilities.Business Wire 01.06.21
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Diagnostics
EKF Introduces Accurate Quantitative COVID-19 Antibody Test Kit
The test kit is one of first to detect both the presence and precise levels of COVID-19 neutralizing antibodies.EKF Diagnostics 01.05.21
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Diagnostics
Mologic COVID-19 Rapid Antigen Test Receives CE Mark Approval
Preliminary results show 92% sensitivity and 100% specificity, compared with RT-PCR.Mologic Ltd 01.05.21
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Diagnostics
Hologic Adds 3D Ultrasound Imaging to SuperSonic MACH 40 System
New software-based application helps clinicians visualize breast anatomy and provides detailed characterization of lesions.Hologic Inc. 01.04.21
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Diagnostics
Decision Diagnostics CEO Charged in COVID-19 Fraud Scheme
Falsely claimed the company developed a 15-second test to detect COVID-19 in a finger prick sample of blood.United States Department of Justice 01.04.21
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Diagnostics
Manufacturer of Rapid Antigen Tests Acquires BIOLAB
BIOLAB acquisition will create jobs and increase Innova's U.S. COVID-19 testing capability.PR Newswire 12.18.20
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Diagnostics
FDA Authorizes Abbott's Rapid, $25 COVID-19 Test for At-Home Use
Telehealth service will take users step-by-step through the sample collection process.U.S. Food and Drug Administration 12.17.20
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Cardiovascular | Diagnostics
Genetesis' CardioFlux Imaging Tech Gains Breakthrough Status
Leverages room temperature magnetometers to noninvasively measure heart’s naturally-generated magnetic fields.Business Wire 12.16.20
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Diagnostics
FDA Authorizes First OTC Fully At-Home Diagnostic COVID-19 Test
The Ellume COVID-19 Home Test is a rapid, lateral flow antigen test.U.S. Food and Drug Administration 12.16.20
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Diagnostics
RSIP Vision Announces New Cardiac Diagnostic Tool for PoC Ultrasound Screening
New algorithmic module provides an automated expert-level assessment of heart function for point of care medical teams.RSIP Vision 12.16.20
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Diagnostics
Abbott's COVID-19 IgG Quantitative Antibody Test Wins EU Approval
Identifies levels of IgG antibodies that attach to the virus' spike protein.Abbott Laboratories 12.16.20
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Diagnostics
FDA, EU Nods for POC Testing on Siemens Healthineers' epoc NXS Host Mobile Computer
Provides critical test results at the point of care in less than a minute.Siemens Healthineers 12.15.20
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Diagnostics
FDA Authorizes First Direct-to-Consumer COVID-19 Test
LabCorp's Pixel test authorized for at-home sample collection with laboratory test processing.U.S. Food and Drug Administration 12.10.20
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Diagnostics
Combo COVID-19, Flu Home Test Gains EUA
FDA authorizes first COVID-19 and flu combination test for use with home-collected samples.U.S. Food and Drug Administration 12.08.20
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Diagnostics
CRISPR-Based COVID-19 Test Uses Smartphone Camera
The rapid, one-step mobile test could help combat the pandemic and fully reopen communities.PR Newswire 12.07.20
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Diagnostics
Handheld DNA ‘Tricorder’ Developed
Device couples with an iPhone app to enable a mobile genetics laboratory.PR Newswire 12.07.20
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Diagnostics
Roche's Elecsys Anti-SARS-CoV-2 S Antibody Test Earns EUA
Detects antibodies against the SARS-CoV-2 spike protein.GlobeNewswire 12.02.20
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Diagnostics
FDA Clears AI-Powered Full Field Peripheral Blood Smear Application
Israel-based Scopio Labs' solution is tailored to augment hematology diagnostics.Scopio Labs 12.02.20
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Diagnostics
ORTHO Optix Reader Available CE Mark Countries
The semi-automated system allows lower-volume transfusion labs to elevate their standard of patient care.PR Newswire 12.01.20
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Diagnostics | Software & IT
FDA OKs Hologic's Genius AI Breast Cancer Detection Software
New deep-learning algorithm helps radiologists detect breast cancers in their early stages.Business Wire 12.01.20
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Diagnostics
RSNA News: RADLogics’ AI-Powered COVID-19 Medical Imaging Solutions
The company’s latest algorithm enhancements to help radiologists distinguish between coronavirus and other abnormalities.RADLogics 11.30.20
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Diagnostics
RSNA News: Siemens Introduces Cios Flow Mobile C-arm System
Easy-to-use system helps make surgical interventions more efficient and patient-friendly.Siemens Healthineers 11.30.20
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Diagnostics
RSNA News: Siemens Unveils Ceiling-Mounted Digital Radiography System
New version of established MULTIX Impact floor-mounted unit also debuts.Siemens Healthineers 11.30.20
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Diagnostics | Software & IT
RSNA News: Royal Philips Introduces IntelliSpace Portal 12
A next-gen Advanced Visualization Workspace with AI capabilities.Royal Philips 11.30.20
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Diagnostics
RSNA News: FDA Clears Siemens’ AI-Rad Companion Software Assistant
AI-based software automates contouring process for organs at risk during radiation therapy planning.Siemens Healthineers 11.30.20
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Diagnostics
RSNA News: Siemens Debuts LUMINOS Lotus Max Fluoroscopy/Radiography System
Automatically reduces patient radiation dose via dedicated organ programs without compromising image quality.Siemens Healthineers 11.30.20
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Diagnostics
Medtech Matters: Point-of-Care Ultrasound
MPO's Sean Fenske speaks with Kevin Goodwin, CEO of EchoNous, about the role ultrasound in a handheld device can play for healthcare.Sean Fenske, Editor-in-Chief 11.24.20
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Patient Monitoring
CE Mark Granted for Automated Glycemic Control and Continuous Diagnostics System
PrecisionOne provides automated glucose regulation and real-time analysis of blood chemistry values for critical care patients.PR Newswire 11.23.20
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Diagnostics
GE Healthcare Pioneers Photon Counting CT with Prismatic Sensors Buy
Gains Deep Silicon detector technology for photon counting computed tomography (PCCT).Business Wire 11.20.20
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Diagnostics
FDA OKs Hologic's Aptima HIV-1 Quant Dx Assay for HIV Diagnosis
First FDA-approved assay for both qualitative diagnosis and quantitative viral load monitoring.Business Wire 11.20.20
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Cardiovascular
Medtech Matters: AI-Enabled Cardiac Diagnostics
MPO's Sean Fenske speaks with Cardiologs’ Mark Toland and Rick Anderson about the rapidly evolving technology to help address cardiovascular disease.Sean Fenske, Editor-in-Chief 11.18.20
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Diagnostics | Surgical
Allotrope Medical's StimSite Wins FDA Nod
Lets surgeons use existing surgical instruments to help locate, identify ureters using electrical stimulation.PR Newswire 11.18.20
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Diagnostics
FDA Authorizes First COVID-19 Home Self-Testing Kit
Lucira Health test provides lab-quality results in 30 minutes or less from home.U.S. Food and Drug Administration 11.18.20
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Diagnostics | Patient Monitoring
Digital Radiology Ushering Innovations in the Medical Imaging Market
Radiology is on the cusp of revolution following the soaring popularity of digital radiography.Online Exclusives Sunil Jha, Research Content Developer, Global Market Insights 11.17.20
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Diagnostics
Hologic Updates Unifi Analytics Platform
Adds new features to improve staff performance.Hologic Inc. 11.13.20
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Chronic Disease | Diagnostics
FDA Clears Lantheus' AI-Enabled Bone Scan Index in Prostate Cancer
Lantheus' software cleared for use on GE Healthcare Xeleris Platform.Business Wire 11.13.20
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Diagnostics
QIAGEN Launches Portable Digital SARS-CoV-2 Antigen Test
Can accurately analyze over 30 samples per hour.Business Wire 11.12.20
