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FDA Grants Emergency Use Authorization for COVID-19 Rapid Antibody Fingerstick Test
The serology test can be used in point-of-care settings, delivering results in 15-20 minutes.
Business Wire
01.21.21
Cardiovascular
FineHeart Successfully Tests Wireless TET System
A breakthrough in treating patients with severe heart failure.
FineHeart
01.18.21
Beckman Coulter Launches High-Throughput COVID-19 Antigen Test in U.S.
Test runs on company’s analyzers are capable of processing up to 200 samples per hour, enabling high throughput screening in 30 minutes.
Beckman Coulter
01.14.21
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
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
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
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
CarThera Starts New Clinical Trial to Test its SonoCloud-9 Device
Study will determine the safe dose of Abraxane to be used with SonoCloud-9 in recurrent glioblastoma patients.
CarThera
01.12.21
Diagnostics
ForaCare Suisse AG Launches COVID-19 Antigen Rapid Test
Provides fast, accurate, and easy-to-interpret test results.
PRNewswire
01.11.21
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
Diagnostics
University of Birmingham Researchers Invent New COVID-19 Test
Delivers accurate results within minutes.
University of Birmingham
01.07.21
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
Thyroid Function Tests Market in India to Reach $125 Million in 2025
Thyroid stimulation hormone tests are expected to account for more than 75 percent of the market.
GlobalData
01.06.21
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
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
FOREFRONT MEDICAL TECHNOLOGY ANNOUNCES UNIQUELY-DESIGNED COVID-19 TEST SWAB
...
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
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
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
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
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
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
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
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
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
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
Diagnostics
QIAGEN Launches Portable Digital SARS-CoV-2 Antigen Test
Can accurately analyze over 30 samples per hour.
Business Wire
11.12.20
Diagnostics
Smartphone-based Solutions Boost Infectious Disease POC Testing Market 70.2 Percent
Study reveals that digital POC platforms will enable diagnostic testing beyond the clinic, transforming how assay results are gathered and analyzed.
Frost & Sullivan
11.10.20
Company Developing a COVID-19 Severity Risk Test for U.S. Government
The technology, known as host-response diagnostics, rapidly reads the immune system using multiple mRNA biomarkers and a machine learning algorithm.
Inflammatix
11.04.20
Diagnostics
How COVID-19 is Reshaping the Diagnostics Testing Sector
The short-term impact on the diagnostics sector is readily apparent as the pandemic has fueled overwhelming demand for effective SARS-CoV-2 testing solutions.
Eric Williams, Managing Director, Capstone Headwaters
11.04.20
Ocutrx Vision Technologies Awarded Two Patents for Visual Field Testing, Dynamic Opacity Innovation
One of the patents covers the company’s visual field perimetry testing technology.
Ocutrx Vision Technologies LLC
11.02.20
Diagnostics
BD to Supply 9.2M COVID-19 Antigen Tests to The Netherlands
First shipment of 1.2 million SARS-CoV-2 assays for the BD Veritor Plus System to be delivered in The Netherlands by mid-November.
PR Newswire
11.02.20
Diagnostics
Imec Developing Five Minute COVID Test
Approach will use virus particles in exhaled breath to identify positive cases and confirm contagion risk.
Imec
10.30.20
Antigen Testing is Crucial in Fight Against COVID-19 in India
Antigen testing can be easily done on the spot in doctor’s clinics, day care centers, hospitals, home care settings, and industries.
GlobalData
10.23.20
Diagnostics
Combination Covid-19, Influenza, RSV Test Receives CE Mark
Allows BD MAX System users to run a single module that tests concurrently for Covid-19, Influenza and Respiratory Syncytial Virus.
BD
10.21.20
3D/Additive Manufacturing
|
Cardiovascular
First-Ever Living, 3D-Bioprinted Aneurysm to Test Surgical Treatments
Represents a significant step to developing patient-specific care for aneurysms.
Lawrence Livermore National Laboratory
10.21.20
Clinical Enterprise Gains EUA for At-Home COVID Test
The at-home COVID-19 nasal PCR test is easy to use and painless.
Business Wire
10.19.20
Diagnostics
DnaNudge, Jabil Healthcare Partner on COVID Test Kits
Key production arrangement will enable high-volume manufacture of CovidNudge testing cartridges on a global scale.
DnaNudge
10.16.20
Diagnostics
Genalyte's Rapid COVID-19 Antibody Test Obtains EUA
Instrument-based, rapid test uses multi-antigen approach.
PR Newswire
10.16.20
Diagnostics
New Blood Test Predicts Which COVID-19 Patients Develop Serious Infection
Measures levels of pro-inflammatory and anti-inflammatory molecules.
PR Newswire
10.14.20
Diagnostics
Abbott's COVID-19 IgM Test Receives EUA
Test demonstrated 99.56 percent specificity, 95 percent sensitivity for patients tested 15 days after symptom onset.
Abbott Laboratories
10.12.20
Diagnostics
Beckman Coulter's SARS-CoV-2 IgM Antibody Test Receives EUA
The test demonstrates 99.9 percent specificity and 98.3 percent sensitivity.
PR Newswire
10.09.20
Diagnostics
|
Testing
GenMark Diagnostics’ ePlex RP2 Receives EUA from FDA
Provides results for more than 20 viruses and bacteria in less than two hours.
GenMark Diagnostics Inc.
10.09.20
Diagnostics
FDA Expands Authorization of Hologic Aptima COVID-19 Test
Now authorized for testing of individuals without symptoms or other reasons to suspect COVID-19 infection.
Business Wire
10.07.20
Qosina Partners with Resolution Medical to Offer a 3D-Printed Sterile Nasal Swab for COVID-19 Testing
...
Diagnostics
Quidel's Rapid Antigen Test for Flu A+B, COVID-19 Gains EUA
Sofia 2 Flu + SARS Antigen FIA point-of-care test delivers 3 results from 1 sample in 15 minutes.
Business Wire
10.05.20
Diagnostics
Beckman Coulter's Access IL-6 Test for COVID-19 Earns EUA
Access Interleukin-6 (IL-6) assay assists physicians in identifying severe inflammatory response in COVID-19 patients.
PR Newswire
10.02.20
Diagnostics
Quest Launches Three New Combined COVID-19, Respiratory Virus Tests
Nearly 20 viral and bacterial infections can be identified from a single swab.
PR Newswire
10.01.20
Diagnostics
OralDNA Labs Gains EUA for Saline Oral Rinse COVID-19 RT-PCR Test
First Emergency Use Authorization for a simple saline 30-second swish and gargle collection.
PR Newswire
09.30.20
Diagnostics
BD's SARS-CoV-2 Antigen Test OKed in Europe
Portable, rapid PoC antigen test to detect SARS-CoV-2 in 15 minutes to be available in Europe by end of October.
PR Newswire
09.30.20
Trending
Portable, Home-Use Device Quickly Measures Inflammation Levels
Masimo Earns CE Mark For New Fingertip Pulse Oximeter
TPI Partners With Zeiss
Top 10 Trends In The Medical Device And Equipment Industry
Understanding Food-Grade Vs. Biocompatibility For Medical Device Materials
Breaking News
Cretex Companies CEO Steps Down
Data Show Porex's Medical Device Filtration Materials Protect Against Virus, Bacteria Spread
Endoscopic Hemostasis Devices Market Valued at $730 Million
Henry Schein Buys Majority Interest in Prism Medical Products
Boston Scientific's Vercise Genus DBS Earns FDA Approval
View Breaking News >
CURRENT ISSUE
November/December 2020
Pharmaceutical Focus: A Look at Combination Products
The Printed World: Additive Manufacturing in Medtech
The Lost Year: 2020 Year in Review
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