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

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

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

Abbott Q4 beat driven by COVID-19 test demand, devices come in flat

CEO Robert Ford said the company exited 2020 with "tremendous momentum" and forecast 35% growth for this year. 

By Greg Slabodkin • Jan. 27, 2021

BD study suggests its COVID-19 antigen test better than PCR at detecting infectious individuals

The findings add to a debate on to how to use the fast-acting tests and their potential to reduce virus spread by enabling interventions. Still, questions remain about how well these diagnostics perform on asymptomatic people.     

By Greg Slabodkin • Jan. 26, 2021

Philips beats Q4 expectations as COVID-19 boosts connected care, slows procedures

The Dutch conglomerate will continue to be active on the M&A front, CEO Frans van Houten told investors, after striking two deals in the space over the past month worth more than $3.4 billion.

By Nick Paul Taylor • Jan. 25, 2021

Healthcare funding shatters records in 2020, helped by COVID-19

Medical device startups raised roughly $6 billion in the fourth quarter, a high point over the last three years, according to a CB Insights report.

By Rebecca Pifer • Jan. 22, 2021

4 key trends for payers and providers in 2021

The COVID-19 crisis may spur speedier adoption of value-based care and partnerships between health systems and payers in the year ahead.

By Samantha Liss • Jan. 22, 2021

ACLA seeks lab reimbursement changes as need for COVID-19 testing surges

Julie Khani, president of the American Clinical Laboratory Association, which includes Quest and LabCorp, says there are coverage gaps and that clarifications are needed for which tests are paid for by insurers.

By Greg Slabodkin • Jan. 22, 2021

Abbott antigen test misses two-thirds of COVID-19 asymptomatic cases: CDC

Compared to gold standard PCR tests, the company's point-of-care BinaxNOW diagnostic had a 35.8% sensitivity when used to analyze samples taken from individuals without symptoms, according to the agency.

By Nick Paul Taylor • Jan. 21, 2021

CMS rejects 1st colorectal cancer blood test, tweaks path for Exact, Guardant and others

The agency removed one of the criteria needed to secure Medicare coverage but still shunned Epigenomics' diagnostic. Rivals have versions in development.

By Nick Paul Taylor • Jan. 20, 2021

Forging trust in AI, sustaining the virtual care boom and other CES takeaways

"You can't just set a piece of software in front of somebody and say 'trust me,'" Christina Silcox, digital health fellow at the Duke-Margolis Center for Health Policy, said at the consumer tech conference.

By Rebecca Pifer • Jan. 19, 2021

Thermo Fisher buys Mesa Biotech for $450M to bolster rapid point-of-care testing

The all-cash acquisition, which includes the potential for an additional $100 million upon completion of milestones, adds Mesa's PCR test platform for SARS-CoV-2, influenza A and B, RSV and strep A to Thermo's portfolio.

By Greg Slabodkin • Jan. 19, 2021

Abbott, Quidel tout big COVID-19 testing year despite vaccine rollout: JPM21

"I don't see COVID just simply going away, but I do see it looking more like a flu-like seasonal test. And if you think about it globally, it's a pretty significant amount of volume," Abbott CEO Robert Ford said at J.P. Morgan's conference.

By Greg Slabodkin • Jan. 15, 2021

CMS breakthrough rule called tailwind for Abbott, J&J and Medtronic

The policy gives developers of FDA-designated breakthrough products coverage for Medicare's 60 million beneficiaries on the day of approval.

By Nick Paul Taylor • Jan. 13, 2021

3 takeaways from JP Morgan: Electives, M&A and looking past COVID-19

Execs from Medtronic, Baxter and BD are among those previewing the year ahead at the bank's annual healthcare conference.

By Greg Slabodkin , Ricky Zipp • Jan. 12, 2021

In medtech win, MDR-IVDR remote audits OK'd amid pandemic pressures

An official for MedTech Europe, which pushed for flexibility ahead of new medical device rules set to kick in later this year, called the move "significant and positive."

By Nick Paul Taylor • Jan. 12, 2021

FDA flags COVID-19 false negative risk from virus variant of Thermo Fisher, Applied DNA and Mesa tests

Sensitivity may be affected by emerging forms of the virus, though the agency said "the impact does not appear to be significant." In fact, the tests may help to spot where a fast-spreading variant is prevalent.

By Nick Paul Taylor • Jan. 11, 2021

Medtech M&A to take off after pandemic slowed deals in 2020: EY

Dealmaking in 2021 will be fueled by financial firepower across the industry at an "all-time high" of nearly $500 billion, according to the consultants.

By Ricky Zipp • Jan. 10, 2021

HHS allocates $300M for Abbott COVID-19 rapid tests or 'equivalent' testing tech

The agency has yet to decide if it will purchase Abbott's or a similar diagnostic from a rival, Assistant Secretary for Health Brett Giroir said Thursday.

By Greg Slabodkin • Jan. 8, 2021