AdvaMed launches COVID-19 test registry to address shortages

Created in partnership with Abbott, Roche, Siemens and others, the database is aimed at helping ensure sufficient testing supply by providing weekly state- and national-level updates on the number of tests shipped.

By Nick Paul Taylor • July 22, 2020

4 healthcare sticking points as Congress weighs next coronavirus relief bill

Senate Republicans may limit allocations for testing efforts, as labs struggle to keep up with demand and return results in a timely enough fashion to leverage contact tracing.

By Rebecca Pifer , Samantha Liss • July 21, 2020

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Medical device industry continues to turn to AI

While the industry continues to embrace artificial intelligence, there are still questions about how the new technologies need to be regulated and if they are effective.

By MedTech Dive staff

FDA eases rules on viral transport media to boost availability for COVID-19 testing

In some cases, a dearth of key materials has constricted efforts to widen COVID-19 testing. Now, the agency is allowing commercial manufacturers to ship products without filing a 510(k) or meeting UDI requirements.

By Nick Paul Taylor • July 21, 2020

Quidel says its COVID-19 antigen test is now on par with PCR accuracy

Results suggest the product is more sensitive than a rival test sold by BD. Some analysts say that could help shore up concerns about the faster, point-of-care tests' accuracy. 

By Greg Slabodkin • July 20, 2020

Quest coronavirus test becomes 1st with FDA OK for sample pooling

The technique is "not a magic bullet," Quest's chief medical officer said, with demand for its COVID-19 services still overwhelming capacity. However, rival LabCorp said it has reduced its average turnaround time for results.

By Maria Rachal • July 20, 2020

Philips sees double-digit COVID-19 connected care bump amid Q2 sales dip

Headwinds won out this spring, dragging total sales down 6%. Still, management predicted the return of elective procedures will help tip the balance to growth for the rest of the year.

By Nick Paul Taylor • July 20, 2020

3 Quest COVID-19 assays get FDA OK for at-home collection via telehealth

The agency this week granted new emergency use authorizations to three tests, previously granted EUAs, so users can self-collect nasal swab samples while being observed by a healthcare provider remotely.

By Greg Slabodkin • July 17, 2020

Thermo Fisher ups Qiagen offer by 10% after investor backlash cites COVID-19 growth

The acquisition was announced weeks before the U.S. doubled down on its need for widespread coronavirus testing, which provided a big business opportunity for Qiagen that it capitalized on during the second quarter.

By Maria Rachal • July 16, 2020

BD sells 750K antigen tests to HHS as COVID-19 nursing home testing scales up

Also included in the government order are 2,000 of BD's point-of-care testing machines to be distributed starting next week in hotspot regions of the U.S.

By Maria Rachal • July 15, 2020

Quest COVID-19 test turnaround times double for priority patients

In an update late Monday, Quest said that while volumes have "stabilized," average turnaround times are still at least a week and some patients may have to wait for up to two weeks.

By Greg Slabodkin • Updated July 21, 2020

Shareholder challenges Thermo Fisher's $11.5B deal to buy Qiagen

COVID-19 has made "significantly clearer" the importance of Qiagen's testing business, according to investment management firm Davidson Kempner, which is urging other shareholders to reject the offer priced in early March.

By Susan Kelly • July 13, 2020

Quest Q2 better than feared, as demand surges for COVID-19 diagnostics

The update on April-through-June revenue comes as lab networks' July testing capacity and results turnaround times are strained by regional outbreaks.

By Maria Rachal • July 13, 2020

Lab groups ask Trump admin for more transparency into COVID-19 testing supply allocation

Eight organizations representing laboratory professionals asked the White House Coronavirus Task Force to address ongoing obstacles to performing tests.

By Greg Slabodkin • July 10, 2020

IVDR implementation by 2022 'highly doubtful,' trade group warns

MedTech Europe is ramping up calls for the European Commission to rethink plans for the roll-in of the In Vitro Diagnostic Regulation in light of the ongoing COVID-19 pandemic.

By Nick Paul Taylor • July 10, 2020

Siemens COVID-19 antibody test beats rivals in head-to-head study

Assays from Abbott, DiaSorin and Roche failed to meet the U.K. public health agency's sensitivity target. None of the tests performed as well as they did in the company-run studies quoted in their instructions for use.

By Nick Paul Taylor • July 10, 2020

Q2 previews show coronavirus diagnostics bump for Thermo Fisher, Quidel, GenMark

Preliminary results suggest near-insatiable demand for COVID-19 tests is offsetting disruption in other parts of the sector.

By Nick Paul Taylor • July 9, 2020

Philips wins $100M tele-ICU contract from VA

The company said it's creating the world’s largest system for providing remote access to critical care expertise, regardless of patient location. 

By Nick Paul Taylor • July 9, 2020

Democrats urge Trump administration to force full payer coronavirus test coverage

The insurance lobby did not refute claims that not all testing is funded in full, particularly for return-to-work programs. Lawmakers said CMS guidance conflicts with legislation meant to spur widespread access to testing.

By Samantha Liss • July 8, 2020

LabCorp, McKesson back COVID-19 ad campaign urging patients to stop 'medical distancing'

The effort by a coalition of providers, payers and other firms is aimed at reviving elective procedures that were largely halted amid the pandemic.

By Shannon Muchmore • July 8, 2020

As LabCorp, Quest feel COVID-19 strain, Trump admin pegs hopes on POC tests

Brett Giroir, the administration's lead for coronavirus diagnostics, said the goal is for rapid point-of-care tests from Abbott, BD and Quidel, performed outside of lab settings, to alleviate commercial testing capacity constraints.     

By Greg Slabodkin • July 8, 2020

FDA warns of false positives with BD coronavirus diagnostic

On the heels of greenlighting BD's antigen test, FDA flagged an issue with its molecular test offering, telling healthcare professionals to treat positive results as “presumptive” and consider confirming findings via a different test.

By Nick Paul Taylor • July 7, 2020

BD launches coronavirus antigen test, 2nd to get FDA emergency use authorization

The rapid, point-of-care diagnostic joins Quidel's, which had been the only option in the category for nearly two months. Still, FDA notes antigen tests are more likely than molecular diagnostics to miss active coronavirus infections.

By Greg Slabodkin • July 6, 2020

CDC gets FDA nod for coronavirus-flu combination diagnostic

The emergency use authorization comes months after BioFire and Qiagen got backing for similar tests and as the coming flu season adds a new complexity to diagnosis.

By Nick Paul Taylor • July 6, 2020

Kroger wins EUA for at-home coronavirus test kit

The grocer will make the home-collection kits available to employees this week and, along with partner Gravity Diagnostics, plans to process up to 60,000 tests weekly by the end of July.

By Jeff Wells • July 1, 2020

Notified body poll finds multi-month waits for COVID-19 conformity assessments

More than half surveyed by the European Commission expect to spend six months to a year processing applications for certain devices addressing coronavirus.

By Nick Paul Taylor • July 1, 2020