Insurers will be required to cover 8 at-home COVID-19 tests per month

After proposing the plan in December, the Biden administration on Monday detailed its plan to have insurers cover rapid tests. Health insurance lobby AHIP warned of potential "hiccups in early days" of implementation.

By Nick Paul Taylor • Jan. 11, 2022

Hologic tops guidance as COVID-19 testing wave delivers another beat

The test maker said it will comfortably beat first-quarter guidance, with demand for coronavirus diagnostics helping the company post preliminary revenues of almost $1.5 billion. Quidel set the tone last week with its own beat. 

By Nick Paul Taylor • Jan. 10, 2022

Explore the Trendline➔

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

Quidel preliminary Q4 revenue beats Street on COVID-19 test sales

Fourth-quarter revenue was more than 35% above the consensus analyst estimate, though it was still down from Quidel's 2020 strong final quarter.

By Nick Paul Taylor • Jan. 7, 2022

Abbott, Quidel COVID-19 antigen tests found to lag PCR in detection of omicron

A small real-world study, which has yet to be peer reviewed, found the rapid tests may fail to detect some omicron cases during the first days of infection.

By Nick Paul Taylor • Jan. 6, 2022

Quest's COVID-19 test results turnaround hits longest wait since 2020

The lab giant is taking an average of two to three days to deliver results for molecular diagnostic tests amid the omicron surge, compared to the one-day turnaround time it achieved throughout most of 2021.

By Nick Paul Taylor • Jan. 6, 2022

Medtechs brace for hit as hospitals warn of omicron impact on surgeries

Healthcare staff shortages and rising COVID-19 admissions are forcing hospitals to cancel elective surgeries and postpone diagnostic and imaging procedures. BTIG sees as much as a 7% revenue hit for exposed companies.

By Nick Paul Taylor • Jan. 5, 2022

Medtech's biggest deals in 2021 and what to expect next

After dealmaking took off last year following a 2020 lull, market watchers anticipate robust M&A ahead in 2022 as companies pursue faster growth and greater scale. 

By Susan Kelly • Jan. 4, 2022

Roche, Siemens at-home tests get EUAs as US faces COVID-19 testing shortage

FDA granted emergency use authorizations to the over-the-counter diagnostics under a new accelerated review program. However, the companies may need months to scale up production.

By Nick Paul Taylor • Jan. 4, 2022

Quidel to buy Ortho Clinical Diagnostics in $6B deal; stock tanks

CEO Doug Bryant said the combined company will have a "broader geographic footprint" thanks to Ortho's reach across 130-plus countries. Quidel's shares fell by as much as 17.8% in Thursday morning trading.

By Greg Slabodkin • Dec. 23, 2021

FDA seeks feedback on 180-day notice period for termination of COVID-19 EUAs

The agency's plan is intended to avoid supply disruptions while moving back toward the regulatory requirements of routine operations.

By Nick Paul Taylor • Dec. 23, 2021

CDRH warns review timelines will remain extended in 2022 as pandemic pressures continue

The FDA's Center for Devices and Radiological Health expects "a gradual transition back toward normal review timelines" next year as COVID-19 has delayed traditional work.

By Nick Paul Taylor • Dec. 22, 2021

Biden stresses need for additional testing supply, plans to distribute 500M free rapid COVID-19 tests

"We have to do more. We have to do better — and we will," President Joe Biden acknowledged on Tuesday, as a surge in omicron cases has put added stress on America's already strained test supply.

By Greg Slabodkin • Updated Dec. 22, 2021

Most COVID-19 medical device EUAs lack documented supporting data: JAMA

The use of "low-quality data" is reasonable at the start of a crisis but FDA should consider raising the standard of evidence after multiple products come to market, according to the authors of the study.

By Nick Paul Taylor • Dec. 21, 2021

EU finalizes staggered rollout of IVDR, removing near-term threat to diagnostic supply

MedTech Europe welcomed the adoption of the amended transitional provisions, which it said mitigate "the immediate and urgent risk" of disruption.

By Nick Paul Taylor • Dec. 21, 2021

Roundup: Omicron variant's impact on COVID-19 tests

As the variant of concern continues to spread worldwide, FDA and test makers have scrambled to assess whether the performance of diagnostics are affected by omicron's viral mutations. Here's what we know so far.  

Updated Dec. 29, 2021

FDA in update says 2 COVID-19 tests fail to detect the omicron variant

Diagnostics from Applied DNA Sciences and Meridian Bioscience are not able to detect omicron, causing false negative results, according to the agency, while Tide Laboratories has fixed the problem with its test.

By Greg Slabodkin • Updated Dec. 29, 2021

3 medtech markets poised to thrive in 2022 despite renewed COVID-19 pressures

While the emergence of the omicron variant is muddying next year's medtech outlook, analysts have identified three niches within the sector best positioned to successfully weather the continued strains on the healthcare system.

By Susan Kelly • Dec. 15, 2021

Senate passes bill to delay 2022 Medicare rate cuts for hundreds of lab tests

Senators late Thursday passed an end-of-year package that will delay the 15% cuts for nearly 600 tests slated to kick in next month. Passed by the House on Tuesday, the bill must still be signed by President Joe Biden to become law.

By Greg Slabodkin • Updated Dec. 10, 2021

Cancer treatments lead latest FDA breakthrough device designations

The agency granted regulatory privileges to therapies for lung cancer and bone metastases from RefleXion Medical and Zetagen Therapeutics, respectively.

By Nick Paul Taylor • Dec. 7, 2021

Thermo Fisher, Verily on FDA list of COVID-19 tests affected by omicron variant

The agency's list focuses on coronavirus diagnostics impacted by S-gene dropout, an occurrence that is most commonly associated with Thermo Fisher Scientific's TaqPath test kits.

By Nick Paul Taylor • Dec. 6, 2021

Congress passes on delay to Medicare rate cuts for lab tests, for now

The American Clinical Laboratory Association wants lawmakers to push off 2022 cuts for nearly 600 lab tests. A stopgap bill late last week did not include a reprieve, but Cowen analysts are optimistic a legislative fix will be found.

By Greg Slabodkin • Dec. 6, 2021

Biden orders private health insurers to cover COVID-19 home tests

Test makers such as Abbott, BD and Quidel could see demand increase as costs for consumers are reimbursable. The White House is also doubling distribution of free at-home tests to uninsured and underserved communities.

By Nick Paul Taylor • Dec. 3, 2021

FDA finds 'low likelihood' omicron will impact COVID-19 PCR, antigen tests

The agency joined the chorus of top testing manufacturers, including Abbott Laboratories, Quidel and Thermo Fisher Scientific, claiming that current coronavirus diagnostics can accurately identify the omicron variant.

By Nick Paul Taylor • Dec. 1, 2021

FDA updates eSTAR ahead of expanding filing template for De Novo submissions

The platform has been available for manufacturers to voluntarily submit 510(k) submissions since September 2020. The agency will start accepting De Novo applications when a final rule takes effect early next year.

By Nick Paul Taylor • Nov. 30, 2021

Abbott, BD join chorus of COVID-19 test makers claiming diagnostics not impacted by omicron variant

Becton Dickinson on Tuesday became the latest testing manufacturer to express confidence that both its rapid antigen and PCR tests will detect the variant, which the World Health Organization says poses a "very high" risk.   

By Greg Slabodkin • Updated Nov. 30, 2021