COVID-19: Page 31
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Endologix files for Ch. 11 bankruptcy, plans to go private
The endovascular stent graft maker received FDA approval earlier this year for its newest abdominal aortic aneurysm technology, but has faced disruptions amid a high-risk recall and delays to elective procedures from COVID-19.
By Maria Rachal • July 6, 2020 -
Master Sgt. Hecht, Matt. (2020). [Photograph]. Retrieved from Flickr.
BD launches coronavirus antigen test, 2nd to get FDA emergency use authorization
The rapid, point-of-care diagnostic joins Quidel's, which had been the only option in the category for nearly two months. Still, FDA notes antigen tests are more likely than molecular diagnostics to miss active coronavirus infections.
By Greg Slabodkin • July 6, 2020 -
CDC gets FDA nod for coronavirus-flu combination diagnostic
The emergency use authorization comes months after BioFire and Qiagen got backing for similar tests and as the coming flu season adds a new complexity to diagnosis.
By Nick Paul Taylor • July 6, 2020 -
Courtesy of Centers for Disease Control and Prevention
BARDA backs push for clinical-grade wearable to detect signs of COVID-19
As companies like Fitbit aim to leverage their wrist-worn devices to monitor for disease symptoms, developers at Northwestern University argue that consumer tech falls short compared to clinical-grade, chest and neck-worn wearables.
By Nick Paul Taylor • July 2, 2020 -
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 -
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 -
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 -
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/MedTech 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
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