COVID-19: Page 31
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Courtesy of Kroger
Kroger wins EUA for at-home coronavirus test kit
The grocer will make the home-collection kits available to employees this week and, along with partner Gravity Diagnostics, plans to process up to 60,000 tests weekly by the end of July.
By Jeff Wells • July 1, 2020 -
Notified body poll finds multi-month waits for COVID-19 conformity assessments
More than half surveyed by the European Commission expect to spend six months to a year processing applications for certain devices addressing coronavirus.
By Nick Paul Taylor • July 1, 2020 -
Adobe Stock
AdvaMed, tech groups urge Congress to make eased telehealth rules permanent
Separately, Jefferies analysts pegged Teladoc, Quest Diagnostics, Exact Sciences and CareDx as beneficiaries of the boost in virtual care that's come during the COVID-19 pandemic.
By Greg Slabodkin • June 30, 2020 -
Alex Wong via Getty Images
HHS 'expects to renew' COVID-19 emergency, spokesperson says
The department did not respond to requests for comment Tuesday morning. The public health emergency is currently set to expire at the end of July.
By Shannon Muchmore • June 30, 2020 -
Jacob Bell
As Beckman enters US COVID-19 antibody market, how do rivals compare?
Comparing the accuracy of the Danaher subsidiary's test to products from big rivals like Abbott, Roche and Siemens Healthineers depends on who's doing the assessment and when a sample is taken.
By Nick Paul Taylor • June 30, 2020 -
Retrieved from Flickr.
Labs warn COVID-19 testing demand will soon top capacity as new hotspots emerge
With the spike in coronavirus cases in the South and West, commercial labs say they don't have the resources to keep up. Quest said in an update late Monday turnaround times for some molecular test results are now 3 to 5 days.
By Greg Slabodkin • Updated June 30, 2020 -
Texas again halts elective surgeries, showing fragile nature of rebound
The renewed restrictions spurred questions about whether states or individual health systems in other hotspots like Arizona and California will enforce similar pullbacks in procedures.
By Maria Rachal • June 26, 2020 -
CMS wants to make home health telemedicine permanent after COVID-19
Agencies would be able to keep using the tech for beneficiaries under the Medicare home health benefit beyond the public health emergency, including remote patient monitoring, according to a proposed rule fact sheet.
By Rebecca Pifer • June 26, 2020 -
Payer coverage of employer, surveillance COVID-19 tests not required, feds say
As return-to-work offerings proliferate from lab and pharmacy giants like Quest, LabCorp and CVS, new federal guidance says health insurers aren't obligated to pay for the testing services.
By Maria Rachal • June 25, 2020 -
"State Public Health Laboratory in Exton Tests for COVID-19" by Governor Tom Wolf is licensed under CC BY 2.0
UK study to validate, compare COVID-19 tests in real-world settings
The hospital arm will assess 10 to 20 new diagnostics the National Health Service has identified as high priority, including those designed to deliver results at the point of care in minutes, which could include Abbott’s ID NOW.
By Nick Paul Taylor • June 25, 2020 -
"Florida National Guard" by The National Guard is licensed under CC BY 2.0
5-minute, quantitative COVID-19 antibody test snags BARDA backing
MBio's offering could assess whether a patient has protective levels of antibodies and is a candidate to donate convalescent plasma, a potential treatment for critically ill COVID-19 patients.
By Susan Kelly • June 24, 2020 -
CVS launches COVID-19 return-to-work service with testing
Questions about testing accuracy and hesitancy by employers haven't stopped big healthcare companies, including Quest, LabCorp and UnitedHealth Group, from jumping into the space with new products.
By Rebecca Pifer • June 24, 2020 -
Jacob Bell
FDA affirms potential to miss MDUFA deadlines, weighs virtual advisory panels
Separately, the agency announced virtual meetings in September on using patient preference information in medical device regulatory decisions and considering patient-reported outcomes in evaluating devices.
By Nick Paul Taylor • June 23, 2020 -
Deep Dive
No silver bullet: LabCorp and Quest hawk return-to-work COVID-19 tests but employers not rushing in
One employer group official noted "hype" around antibody testing with inconclusive evidence about the immunity of individuals who test positive for the antibodies.
By Greg Slabodkin • June 22, 2020 -
"Man in face mask in front of Union Station at 50 Massachusetts Avenue, NE, Washington DC on Thursday morning,19 March 2020" by Elvert Barnes Photography is licensed under CC BY-SA 2.0
BARDA backs study of Empatica's COVID-19 early warning platform
The system, which measures physiological data including blood volume pulse and electrodermal activity, is the latest in a growing list of wearables being primed to detect and monitor infections.
By Susan Kelly • June 22, 2020 -
Trump admin sitting on $14B for testing, tracing, Democratic senators say
A letter urging the administration to ramp up its COVID-19 spending comes a day after President Donald Trump told a rally he had directed officials to slow down testing to keep case numbers low.
By Rebecca Pifer • June 22, 2020 -
Moody's: US healthcare system rebounds from COVID-19 in May, but uneven road lies ahead
Last month saw improvement in care volumes, but recent pullbacks in hot spots like Arizona may exemplify the bumpiness to come for recoveries at medical device companies.
By Ron Shinkman • June 19, 2020 -
Dufour, Tia. (2020). "White House Press Briefing" [Photograph]. Retrieved from Flickr.
Pandemic pushes FDA to 'accelerate' real-world evidence efforts, Hahn says
The agency has grappled with how to leverage real-world data in regulating medical devices, and is now leaning on it to update emergency use authorizations, FDA chief Stephen Hahn said at a forum on Thursday.
By Maria Rachal • June 19, 2020 -
Screenshot of virtual Senate HELP hearing, June 17, 2020
Senators back sustaining telehealth momentum post pandemic
Top priorities include axing geographic restrictions, expanding Medicare and Medicaid reimbursement for virtual care services, and upping use of remote patient monitoring and digital health tools for patients with chronic conditions.
By Rebecca Pifer • June 18, 2020 -
Jacob Bell / BioPharma Dive
FDA cracks down on sellers of at-home COVID-19 antibody tests
A series of warning letters is the latest example of U.S. regulators weeding out serology tests that don't meet the agency's standards.
By Nick Paul Taylor • June 18, 2020 -
FDA revokes emergency authorization for Chembio's COVID-19 antibody test
It's the first time the agency has exercised such authority for a coronavirus test, citing more false results than expected. Chembio Diagnostics' stock plunged 60% Wednesday.
By Greg Slabodkin • June 17, 2020 -
NIH loops Quest into effort to test 10K Americans for antibodies against coronavirus
The agency did not disclose which antibody test it will use as part of the All of Us initiative, saying only that the assay has FDA emergency use authorization and is designed to detect IgG antibodies.
By Nick Paul Taylor • June 17, 2020 -
Labs urge CDC to change COVID-19 antibody test guidelines
The trade group for Quest Diagnostics and LabCorp criticized the federal agency's advice against use of serology test results to make decisions about who can return to work.
By Nick Paul Taylor • June 16, 2020 -
Moody's lowers medtech earnings forecast, pegs J&J, Zimmer among hardest hit by COVID-19 fallout
The ratings agency expects the pandemic to curb sales of the large, mostly investment-grade medtechs it covers by 10% this year, with earnings dropping as much as 30%.
By Nick Paul Taylor • Updated June 15, 2020 -
Master Sgt. Hecht, Matt. (2020). [Photograph]. Retrieved from Flickr.
COVID-19 diagnostic testing costs may hit $25B per year, AHIP study finds
And on the antibody testing front, costs could range between $5.2 billion and $19.1 billion, according to a report commissioned by the payer trade group.
By Shannon Muchmore • June 11, 2020
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