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Biotech Team Develops ELISA Protocol for COVID-19 Antibody Detection
The new detection method can help determine whether patients have had COVID-19 and if they might still have immunity to the disease.
Michael Barbella
01.22.21
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
OraSure’s OMNIgene·ORAL Device Included in COVID-19 EUA Amendment
Amendment will allow 3B BlackBio Biotech’s North American distributor to expand saliva COVID-19 PCR-based viral diagnostic testing across the U.S.
OraSure Technologies Inc.
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
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
Rapid Screening App Uses Wearable Sensor Data to Detect COVID-19 Infection
New screening tool proves almost twice as effective as temperature checks in predicting coronavirus.
NeuTigers
01.13.21
Researchers Receive Funding to Develop Smart Vaccine Device
New smart patch will deliver the COVID-19 vaccine and measure its efficacy through monitoring the body's associated response.
Swansea University
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
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
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
Diagnostics
University of Birmingham Researchers Invent New COVID-19 Test
Delivers accurate results within minutes.
University of Birmingham
01.07.21
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
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
Face Mask Filters 98 Percent of COVID-19 Particles
Patented process sets new standard in pandemic PPE protection, surpassing N95 masks in efficacy.
Medicevo Corporation
01.04.21
Modulim Granted CE Mark for Clarifi Imaging System for Microvascular Assessment
Clarifi is the newest advancement for assessing tissue and microvascular function.
Business Wire
01.04.21
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
CorVent, Siemens Healthineers Ink RESPOND-19 Ventilator Distribution Deal
U.S. agreement expands Siemens Healthineers respiratory care portfolio to include critical care ventilators.
PR Newswire
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
Patient Monitoring
'Smart Ring' Could Spot a Fever Before You Feel It
Advance could pave the way for early warning system on COVID-19 and flu using wearables.
University of California - San Diego
12.14.20
Cardiovascular
Innovative Health Obtains Patent for Microlumen Reprocessing Technology
Paves the way for future innovation in the field by the company.
Innovative Health Inc.
12.11.20
Anti-COVID-19 Nasal Spray is ‘Ready for Use in Humans’
The spray was developed using compounds already approved by regulatory bodies in the United Kingdom, Europe, and the United States.
University of Birmingham Enterprise
12.10.20
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
FDA Authorizes CorVent's RESPOND-19 Ventilator for Multiple Patient Use
Provides reliable and affordable deployment to treat more patients during surges in clinical demand.
PR Newswire
12.09.20
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
Molding
A 'Trial and Error' Approach to Micromolded Parts
The medical industry's stringent requirements makes innovation difficult for injection-molded components.
Online Exclusives
Michael Barbella, Managing Editor
12.07.20
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
Molding
Tooling Precision is Key to Micromolding Success
Tool quality dictates part quality for all sizes of medical components.
Online Exclusives
Michael Barbella, Managing Editor
12.03.20
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
RSNA News: Royal Philips Introduces Patient Management System
Offers personalized care to patients during the COVID-19 pandemic.
Royal Philips
11.30.20
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
Molding
Smaller Cavity Features Not Always Sensible for Micromolded Products
Though the need to reduce size is crucial, small cavity characteristics may be challenging to reproduce in volume.
Online Exclusives
Michael Barbella, Managing Editor
11.24.20
Software & IT
GE Healthcare Launches X-ray AI for COVID-19 Patients' Endotracheal Tube Placement
A necessary and important step when ventilating critically ill COVID-19 patients.
Business Wire
11.23.20
Thirteen Percent Revenue Shortfall Expected in Capsule Endoscopes Market
Market was down nearly 60 percent in Q2 as COVID-19 forced the cancellation or postponement of elective procedures.
GlobalData
11.19.20
Pandemic Could Help Indonesia Strengthen Medical Device Sector
The country aims to produce 70 percent of its medical supplies domestically as it realizes the need for being self-reliant.
GlobalData
11.19.20
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
University Develops AI Algorithm to Analyze Chest X-Rays for COVID-19
Academic team created algorithm using 100,000 X-rays of patients who did not have COVID-19 and 18,000 X-rays of patients who did.
Globe Newswire
11.10.20
Diagnostics
GenScript's SARS-CoV-2 Neutralizing Antibody Detection Kit Wins EUA
Only EUA authorized virus-free testing assay that detects neutralizing antibodies within an hour.
PR Newswire
11.09.20
physIQ, Purdue University Studying Feasibility of COVID-19 Detection Through Smartwatch Data
Data from the study will inform new algorithms to be developed by physIQ, a Purdue-affiliated digital health technology company.
Business Wire
11.09.20
Company Develops COVID-19 Breathalyzer
The innovation incorporates technology from the company's flagship marijuana breathalyzer.
Globe Newswire
11.06.20
PrimeStore MTM Viral Transport Media Evaluated for Coronavirus Inactivation
The patented transport media can help to increase COVID-19 testing capacity.
EKF Diagnostics
11.06.20
The Lost Year: 2020 Year in Review
Lessons learned from the global coronavirus pandemic.
Michael Barbella, Managing Editor
11.04.20
Fixing Face Mask Form and Function
Masks for the general public are varied in both style and effectiveness.
Sam Brusco, Associate Editor
11.04.20
Virtually the Same? The Challenges of Online Conferences
Like everyone else on the planet, I’m turning increasingly to virtual solutions to our physical challenges in the midst of a pandemic.
Dawn A. Lissy, Founder & President, Empirical
11.04.20
Digital Health
Digital Health Delivers During a Year for the Ages
Internet of Medical Things technologies have emerged as the key enabler of a much more holistic and complete disease-state management toolbox.
Brad Womble, Senior Director of Strategy, Marketing, and Mergers & Acquisitions, Jabil Healthcare
11.04.20
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
Trending
Masimo Earns CE Mark For New Fingertip Pulse Oximeter
Portable, Home-Use Device Quickly Measures Inflammation Levels
Understanding Food-Grade Vs. Biocompatibility For Medical Device Materials
Telemedicine, Regulatory Changes To Characterize Medtech Industry In 2021
Medtech Matters: Surgeons Scrubbing In Virtually
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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