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Diagnostics
FDA OKs Canon Medical's AI-Powered, 90cm Bore CT
Company claims the Aquilion Exceed LB CT offers the industry's largest bore opening.Sam Brusco, Associate Editor 01.21.21
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Diagnostics
RSIP Vision Announces Versatile Medical Image Segmentation Tool
Delivers efficient anatomical measurements and better treatment options.RSIP Visions 01.20.21
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Diagnostics
Thermo Fisher Buys Mesa Biotech for $450M
Mesa Biotech developed, commercialized a PCR-based rapid POC testing platform for detecting infectious diseases.PR Newswire 01.20.21
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Cardiovascular | Patient Monitoring
Hillrom to Buy Bardy Diagnostics for $375M
Advances digital health offering with expansion into attractive ambulatory cardiac monitoring segment.PR Newswire 01.19.21
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Diagnostics
Owlstone Medical Introduces Breath Biopsy Panel for Respiratory Diseases
Supports research to distinguish between different types of chronic inflammatory airway diseases.Owlstone Medical 01.19.21
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Cardiovascular | Diagnostics
FDA OKs MRI for Impulse Dynamics' Optimizer CCM Delivery Systems
FDA clears potential hurdle for many heart failure patients.Business Wire 01.19.21
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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
