IVD

Pool of Antibody Tests Continues to Grow

Siemens Healthineers is the latest company to secure Emergency Use Authorization for a test to detect the presence of SARS-CoV-2 antibodies including IgM and IgG in blood.

Quest Wins EUA for COVID-19 Self-Collection Kit

The Secaucus, NJ-based company initially won emergency use authorization for a COVID-19 test in March.

InspectIR Systems Launches Trial for Mobile Device to Detect COVID-19

InspectIR Systems has launched a clinical trial focused on using a mobile device for the detection of the novel coronavirus (COVID-19).

16 Medtech Companies with Innovations Centered Around COVID-19

Here are 16 medtech startups that have developed technologies related to the ongoing coronavirus pandemic.

Abbott Lands IgG Antibody Testing Contract with U.K. Government

The company plans to send millions of tests to the U.K. and has already provided 800,000.

3 Roche Companies Hope to Make Clinical Trials More Efficient

Flatiron Health, Foundation Medicine, and Genentech have launched the Prospective Clinico-Genomic (PCG) feasibility study. The trial will pilot the use of a technology-enabled prospective data collection platform to facilitate, streamline, and simplify the execution of clinical trials for patients living with advanced lung cancer.

Medtech in a Minute: Abbott Gets Defensive, Breast Implant Makers Land in Hot Water, and More

Pressed for time? Here's the medtech news you need most, in one minute or less. Now available as a micro-podcast.

The Number of COVID-19 Tests Keeps Growing with New Hologic Diagnostic

Hologic said it has won Emergency Use Authorization for the Aptima SARS-CoV-2 test. This is the second EUA the Marlborough, MA-based company has received for a COVID-19 test.

Abbott Defends the Accuracy of Its Rapid COVID-19 Test

In a bonus episode of MD+DI's new Medtech in a Minute podcast, News Editor Amanda Pedersen reports on breaking news about Abbott's rapid molecular diagnostics test for COVID-19.

Thermo Fisher Enlists WuXi and Mayo Clinic for New Serology Test

This marks the continuation of a flurry of activity for Thermo Fisher Scientific. In the past few months, the company has announced a huge acquisition; Emergency Use Authorization, and CE mark.

Ortho Clinical Diagnostics Brings in CE Mark for Antibody Test

The Raritan, NJ-based company’s antibody test being granted CE mark comes shortly after it received emergency use authorization from FDA. It also comes on the heels of Abbott Laboratories’ antibody test receiving positive marks from University of Washington researchers.