COVID-19: Page 19
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Jacob Bell / BioPharma Dive
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 -
Jacob Bell
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 -
National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Micrograph]. Retrieved from Flickr.
Why this week's FDA meeting on J&J's coronavirus vaccine will be important
The agency is widely expected to OK the one-dose shot, but the advisory panel will offer a window into debate over several key issues, including related to the new virus variants.
By Ben Fidler , Ned Pagliarulo • Feb. 22, 2021 -
Permission granted by Quidel Corporation
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 -
Retrieved from Manatt on February 18, 2021
Obama admin alum Chiquita Brooks-LaSure tapped to head CMS
AdvaMed backed the nomination, noting a new Medicare rule that gives developers of FDA-designated breakthrough devices the potential to sell them and be reimbursed on the day of market approval.
By Shannon Muchmore • Feb. 18, 2021 -
Hospital admissions not linked to COVID-19 plunged in fall, especially in Midwest
As hospital volumes dropped in 2020, the effects rippled out to large medtechs, many of which rely on elective care to drive revenues.
By Samantha Liss • Feb. 18, 2021 -
Smith & Nephew Q4 knee sales plummet, exceeding drops reported by Stryker and Zimmer Biomet
A challenging quarter was expected after orthopaedic rivals saw pressure on electives, but the scale of losses surprised investors.
By Nick Paul Taylor • Feb. 18, 2021 -
Brian Tucker
COVID-19 EUAs drive FDA to record 2020 novel device OKs
The tally tops the 106 novel device authorizations in 2018 that marked a 40-year high.
By Susan Kelly • Feb. 17, 2021 -
Fotolia
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 -
Getty Images
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 -
Getty
COVID-19 leads to explosion in cyberattacks, data breaches
A survey from CI Security found successful hacks involving healthcare organizations or their business associates soared in the second half of last year, leading to a jump in the number of breached patient records.
By Ron Shinkman • Feb. 12, 2021 -
Getty Images
Abbott, Medtronic could benefit as spinal cord stim seen rebounding
Physicians plan to prescribe 28% more implants than last year, driving sales above the high hit in 2019, according to a survey of 50 doctors by Baird Equity Research.
By Nick Paul Taylor • Feb. 12, 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 -
What medtech earnings tell us so far: COVID-19 testing, electives hit, and M&A
Uncertainty clouds 2021 for medtechs, with elective care likely not to rebound until the second half and testing demand vulnerable to vaccine rollouts. What's clear is that the virus is a moving target and predictions are precarious.
By Ricky Zipp , Greg Slabodkin • Feb. 11, 2021 -
Jacob Bell
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 -
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 -
Pandemic habits could cause US health spending to decelerate over 2 decades, Deloitte predicts
The consultancy's predictive modeling based its estimate on the rise of digital health products and more consumer engagement. Such a slowing contrasts more dire spending forecasts made prior to the COVID-19 crisis.
By Rebecca Pifer • Feb. 8, 2021 -
Getty Images
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 -
Zimmer takes electives hit in Q4, to spin off spine, dental units
"There's just no doubt that COVID, unfortunately, remains a challenge ... We're seeing the pandemic pressure and the surges continue and, frankly, worsen across pretty much all of our regions and markets," said CEO Bryan Hanson.
By Ricky Zipp • 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 -
Courtesy of Roche
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
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