FDA lays path to weigh virus variant impact on COVID-19 test results

The agency wants diagnostic companies to factor the potential for variants to evade detection into their test development and monitoring, Center for Devices and Radiological Health chief Jeff Shuren said.

By Nick Paul Taylor • Feb. 23, 2021

FDA starts review of how skin pigmentation affects pulse oximeter results

The agency is evaluating published literature related to factors that may affect device accuracy and performance, following pressure from senators to address concerns that "racism may be embedded in key clinical tools."

By Nick Paul Taylor • Feb. 22, 2021

Explore the Trendline➔

New medical devices are reshaping the medtech industry

From pulsed field ablation devices to glucose sensors and surgical robotics, new medical technologies are transforming patient care and how people manage their health.

By MedTech Dive staff

Quidel mulls entering new COVID-19 testing markets after another bumper quarter

The point-of-care diagnostics maker sold $678.7 million in kits in the fourth quarter, up 81% sequentially, and is assessing whether it has the capacity to support antigen tests for retail, travel, entertainment and sports. 

By Nick Paul Taylor • Feb. 19, 2021

Exact Sciences-Guardant rivalry in colorectal testing market heats up

Exact bolstered its play for the residual disease and recurrence segment by striking a deal to buy Ashion Analytics, while Guardant disclosed availability of its liquid biopsy test for the same market.

By Nick Paul Taylor • Feb. 17, 2021

One-third of US adults postponed care during pandemic: reports

Among those surveyed, 25% put off dental care, while 21% put off checkups and 16% put off screenings or medical tests, researchers from the Urban Institute and RWJF found.

By Ron Shinkman • Feb. 16, 2021

FDA admits COVID-19 antibody test policy was 'flawed,' offers lessons for future outbreaks

Writing in the New England Journal of Medicine, agency officials acknowledged "touting the potential usefulness" of serology tests early in the pandemic contributed to flooding the market with poorly performing diagnostics.

By Nick Paul Taylor • Feb. 16, 2021

In run-up to MDR, EU posts guide to legacy devices in Eudamed

The guidance explains when manufacturers need to register on the new database and walks through details such as how to link products covered by the outgoing and new regulatory frameworks.

By Nick Paul Taylor • Feb. 15, 2021

LabCorp warns COVID-19 testing sales could plummet as crisis abates

The laboratory giant's willingness to put a figure on the projected hit as vaccines take hold, in this case a dire 35% to 50% drop in revenues this year, contrasts with its chief rival Quest Diagnostics. 

By Nick Paul Taylor • Feb. 11, 2021

Visby gets FDA nod for single-use, rapid point-of-care COVID-19 PCR test

The palm-sized diagnostic gives results in 30 minutes without the need for additional instruments or readers. While Abbott's ID Now provides results in 13 minutes or less, it is the size of a toaster and requires a cartridge. 

By Greg Slabodkin • Feb. 10, 2021

Qiagen shuns M&A that 'dilutes' its focus amid reports of Quidel merger

Qiagen’s CEO said his business development team is focused on bolt-on acquisitions that support and strengthen its operations in five target areas.

By Nick Paul Taylor • Feb. 10, 2021

Heart disease devices lead latest batch of FDA breakthrough nods

The cardiovascular-focused products are part of a wider group of designations including those in development at companies such as Roche. 

By Nick Paul Taylor • Feb. 10, 2021

Alinity, da Vinci top hospital purchasing execs' wish lists: UBS

The feedback from hospitals' purchasing executives, gathered in the fourth quarter of 2020, shows capital equipment budgets remain resilient in the face of COVID-19.

By Susan Kelly • Feb. 9, 2021

Report of Quidel-Qiagen tie-up makes 'no sense,' Wall Street analysts say

Bloomberg reported the two companies are in early discussions. But while one analyst said it was a "plausible, though far-fetched" combination to create a global diagnostics firm, several questioned the wisdom of a union.

By Greg Slabodkin • Feb. 9, 2021

Roundup: Medtech earnings season continues to show COVID-19 uncertainty

BD, Quest Diagnostics and Roche all said they have a clearer view of the first quarter of 2021 but not the second half of the year, while Boston Scientific forecast electives pressure in the first quarter recovering in the second half.

Feb. 5, 2021

Abbott antigen test cuts in-school COVID-19 infections in pilot study, but raises challenges

One limitation noted by researchers looking at 6 U.S. cities: "While we can hypothesize that antigen tests can solve the cost and time limitations of PCR testing, we have no idea how well the tests work in children." 

By Nick Paul Taylor • Feb. 5, 2021

Roche diagnostics revenues up 28% fueled by COVID-19 antigen test demand

"The first half year is very clear. This is where we have most of our ... COVID sales for 2021. And then in the second half year, we'll see how certain things develop," the unit's CEO Thomas Schinecker told investors.

By Nick Paul Taylor • Feb. 4, 2021

Coronavirus uncertainty clouds Quest's 2d half amid Q4 revenue bump

CEO Steve Rusckowski said he expects 2021 to be a strong year for COVID-19 testing, but the lab network predicts demand will likely decline throughout the year as more people are vaccinated.

By Greg Slabodkin • Feb. 4, 2021

BD posts better-than-expected COVID-19 test sales, but flagship Veritor revenues to slow

Coronavirus testing revenues totaled $867 million, primarily made up by sales for the Veritor antigen test. Execs cited new virus variants and the potential for further slowing in elective care for a conservative forecast. 

By Ricky Zipp • Feb. 4, 2021

PerkinElmer predicts sharp falloff in COVID-19 sales this year

In a relatively rare admission by a testing company, execs said they expect around 50% of 2021 coronavirus sales to come in the first quarter, beyond which vaccines are tipped to drive down demand.

By Nick Paul Taylor • Feb. 3, 2021

DoD awards Ellume $231M to increase US production of at-home, OTC COVID-19 test

The Australian diagnostics company will use the funding to establish a U.S. manufacturing facility that is projected to increase production capacity by 640,000 tests per day by December.

By Susan Kelly • Feb. 2, 2021

Thermo Fisher Q4 fueled by COVID-19, but testing demand seen slowing in 2021

J.P. Morgan analyst Tycho Peterson noted the medtech's expected testing drop-off in 2021 is "steeper than what we've heard from others such as Hologic and Abbott."

By Greg Slabodkin • Feb. 1, 2021

From COVID-19 EUAs to 'insidious' remote care risks: ECRI's top 10 medtech hazards

Risks highlighted by the watchdog include FDA emergency use authorizations and the rapid adoption of telehealth, both of which have increased during the coronavirus pandemic.

By Susan Kelly • Feb. 1, 2021

Siemens Q1 boosted by antigen tests, routine work normalizing

"We should not miss the fact that a fair share of this revenue growth would likely not have been there without the pandemic-related demand," CFO Jochen Schmitz acknowledged.

By Nick Paul Taylor • Feb. 1, 2021

4 key trends for medtech in 2021

With resurgence of the coronavirus and emergence of more contagious strains, COVID-19 challenges, but also opportunities, lie ahead for medical device and diagnostics companies.

By Greg Slabodkin • Jan. 29, 2021

England's NHS moves to boost access to Quidel, Roche, other medtech products

To be a part of the National Health Services' MedTech Funding Mandate, companies must be able to make the claim that their products generate net savings in their first year of use.

By Nick Paul Taylor • Jan. 27, 2021