The past 12 months of pandemic, social unrest and a divisive election – provided a crash course in crisis management for CEOs. In this week’s DeviceTalks Weekly Podcast, Kevin Lobo, the CEO of Stryker, explains how he led his company through this this difficult year. His recipe for success is long, but it includes priorities, […]
Quest Diagnostics Inc.
The top 5 MassDevice stories of the week — December 11, 2020
The medtech industry continues to plug along as major news comes in about vaccines, the incoming presidential administration and more. This week’s top stories include the latest on COVID-19, Joe Biden and some additional FDA clearances, plus a major royalties spat. Want to hear more about the week’s top medtech news on MassDevice? Tom Salemi will […]
FDA authorizes at-home COVID+flu test from Quest Diagnostics
The FDA has given emergency use authorization for a COVID-19 and flu combination diagnostic from Quest Diagnostics (NYSE:DGX). In a letter to San Juan Capistrano, Calif.-based Quest Diagnostics, the FDA said that, while it has approved tests for influenza A and influenza B, there are no FDA-approved multiplexed tests for flu/SARS-CoV-2 combination testing. Additionally, no self-collected, […]
MedTech 100 roundup: Stagnant week for industry
Medtech stocks made a run at a new peak over the past week, but ultimately remained mostly unchanged from the previous seven days. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — finished last week at 89.3 (Sep. 18), marking a 0.3% gain from the 89.03 points registered at […]
Quest lets consumers order COVID-19 tests online
Quest Diagnostics (NYSE:DGX) today announced that consumers will be able to order one of its COVID-19 diagnostics online and collect the specimen at home, without visiting a doctor’s office. QuestDirect Active Infection is also available by drive-through at more than 500 Walmart Neighborhood Market locations. Results are interpreted by a physician and provided digitally through the […]
Hologic applies for pooled COVID-19 testing nod
Hologic (NSDQ:HOLX) announced today that it has self-validated use of its Aptima and Panther Fusion molecular diagnostic COVID-19 assays with pooled patient samples and applied for an FDA emergency use authorization (EUA) for pooled testing. Marlborough, Mass.-based Hologic is the third major company to announce it is seeking such authorization. Quest Diagnostics (NYSE:DGX) gained a pooled-sample testing […]
New Quest lab method gains FDA nod
Quest Diagnostics (NYSE:DGX) announced that it received FDA emergency use authorization (EUA) for a new laboratory technique for extracting viral RNA. Secaucus, N.J.-based Quest Diagnostics’ new technique is designed to speed up the process of extracting viral RNA from specimens in an effort to expand daily capacity of COVID-19 molecular diagnostic tests in the U.S., according […]
LabCorp COVID-19 test may be used on asymptomatic people
The FDA on Friday added two new indications for the use of a Laboratory Corporation of America (NYSE:LH) COVID-19 RT-PCR diagnostic: to test people who have no symptoms of the virus or have no reason to believe they’ve been exposed; and to allow pooled testing of up to five samples from different people. The test, which received an emergency […]
Quest COVID-19 test wins FDA nod for pooled sampling
The FDA has authorized a Quest Diagnostics (NYSE:DGX) test for COVID-19 to be used with pooled samples — the first such authorization by the agency since Dr. Anthony Fauci, the nation’s leading infectious disease specialist, started publicly discussing pooled-sample testing about three weeks ago. The authorization, announced Saturday, permits the pooled testing of up to four […]
Quest lands FDA nod for at-home COVID-19 test
Quest Diagnostics (NYSE:DGX) has received an FDA emergency use authorization (EUA) for an at-home diagnostic test for COVID-19. The Secaucus, N.J.-based testing giant said the test kit is for individuals to self-collect a nasal specimen at home or in a healthcare setting when determined to be appropriate by a healthcare provider. It allows an individual to […]
Quest Diagnostics launches patient-ordered COVID-19 antibody test
Quest Diagnostics (NYSE:DGX) announced today that consumers can now order a COVID-19 antibody test it launched last week directly from the company, without visiting a doctor’s office. The Secaucus, N.J.-based testing giant said consumers can purchase the antibody test service online for $119 through its QuestDirect business. They will be prompted to schedule an appointment for […]
