Diagnostics: Page 35
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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 -
Courtesy of Qiagen
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 -
Explore the Trendline➔
Sara Silbiger via Getty Images
TrendlineTop 5 stories from MedTech Dive
From haphazard layoffs at the Food and Drug Administration to the industry’s current IPO environment and tracking FDA-authorized AI devices, here is a collection of top stories from MedTech Dive.
By MedTech Dive staff -
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 -
Permission granted by The Boldt. Co.
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 -
Permission granted by Quidel Corporation
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 -
Courtesy of Abbott Labs
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 -
Courtesy of Quest Diagnostics
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 -
Courtesy of BD/PRNewswire
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 -
Courtesy of Ellume Health
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 -
[Photograph]. Retrieved from Regional Health Command Atlantic.
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 -
Courtesy of Siemens Healthineers
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 -
Adeline Kon/MedTech Dive
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 -
Courtesy of Abbott
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 -
Courtesy of BD/PRNewswire
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 -
Brian Tucker/MedTech Dive
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 -
"State Public Health Laboratory in Exton Tests for COVID-19" by Governor Tom Wolf is licensed under CC BY 2.0
Q&AACLA 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 -
Courtesy of Abbott Labs
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
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