COVID-19: Page 14
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Sarah Silbiger via Getty Images
PMA apps could hit record in 2021, pressuring a pandemic-stressed FDA
Despite increased workloads from the coronavirus crisis, the agency is also on track to issue record numbers of safety warnings and letters to healthcare providers in 2021, according to a Wells Fargo analysis.
By Nick Paul Taylor • July 2, 2021 -
Abbott
COVID-19 antigen testing on par with PCR when used often: NIH-funded study
The two diagnostic methods were equally effective in detecting SARS-CoV-2 infection. The results could be good news for antigen test makers Abbott, Becton Dickinson and Quidel.
By Greg Slabodkin • July 1, 2021 -
Roundup: Trial results, looming product releases fuel diabetes tech competition
In the first half of the year, the space is meeting Wall Street’s high expectations for 2021. Here’s a roundup of MedTech Dive’s coverage of the market, including from this week’s American Diabetes Association meeting.
June 30, 2021 -
Courtesy of Abbott
Abbott gets CE mark to sell COVID-19 antigen test directly to consumers in Europe
The company’s rapid Panbio diagnostic received the marking in January for asymptomatic coronavirus screening. However, the test missed half of COVID-19 cases in people without symptoms, according to a recent Irish study.
By Greg Slabodkin • June 28, 2021 -
Permission granted by E.A. Crunden
Lawmakers reintroduce diagnostic regulation bill that split the industry
The VALID Act would create a risk-based regulatory framework for in vitro diagnostics and laboratory-developed tests. ACLA, whose members include Quest and LabCorp, is reviewing the bill but has objected to earlier drafts.
By Nick Paul Taylor • June 25, 2021 -
Medicare lacks cyber oversight of hospitals’ networked medical devices: OIG
Without proper cybersecurity controls, these devices can be compromised with the potential for patient harm, according to the HHS watchdog. OIG wants CMS to do more to address hospital vulnerabilities.
By Nick Paul Taylor • June 24, 2021 -
An Rong Xu via Getty Images
AdvaMed urges Biden to prioritize medical supplies as industries suffer shipping constraints
CEO Scott Whitaker said transport challenges, including shipping container shortages and insufficient trucking capacity, have impeded the ability of medtechs to deliver products while also significantly driving up costs.
By Ricky Zipp • June 23, 2021 -
Adeline Kon/MedTech Dive
Black patients were more likely to die of COVID-19 largely due to inferior hospitals
A recent study in JAMA Network Open showed how inequities in housing influence where Black people seek care and how that affects the quality of care they receive.
By Samantha Liss • June 21, 2021 -
Courtesy of Siemens Healthineers
UnitedHealthcare skimping on COVID-19 test pay: California doctors group
The California Medical Association says UnitedHealthcare still is not covering the cost of all COVID-19 diagnostic testing, despite state and federal guidelines that require the services to be provided at no cost to patients.
By Susan Kelly • June 21, 2021 -
Medicare CGM eligibility widened in potential boon for Abbott, Dexcom
CMS opened up coverage for therapeutic continuous glucose monitors, eliminating a rule that patients must use a blood glucose monitor and require at least four self-monitoring blood glucose tests per day to have devices covered.
By Ricky Zipp • June 18, 2021 -
UK extends OK of Innova COVID-19 test criticized by FDA in warning letter
While U.S. regulators told the public to put Innova tests in the trash, a review by the U.K. counterpart found no problems that warranted further actions.
By Nick Paul Taylor • June 18, 2021 -
Courtesy of Abbott
Abbott’s Panbio antigen test misses half of asymptomatic COVID-19 cases in Irish study
The finding led Ireland to recommend against using single, standalone antigen kits for the purposes of such screening.
By Nick Paul Taylor • June 15, 2021 -
Courtesy of Humana
Humana acquires Onehome to pursue value-based home health strategy
The deal for Miramar, Florida-based Onehome follows the insurer’s recent purchase of home health giant Kindred at Home for $5.7 billion.
By Rebecca Pifer • June 15, 2021 -
National Institute of Allergy and Infectious Diseases. (2020). “Novel Coronavirus SARS-CoV-2” [Image]. Retrieved from Flickr.
FDA blasts Innova for shipping unapproved COVID-19 test, using false or misleading labeling
The agency hit the California-based medtech with a flurry of actions on Thursday, firing off a warning letter alongside notice of a Class I recall and a press release telling the public to stop using the antigen test.
By Nick Paul Taylor • Updated June 11, 2021 -
Medtronic’s FDA approval sets up fight for recharge-free pain market
The medtech sees Vanta helping it gain share in a market it has struggled to penetrate in the past. Abbott Laboratories, Boston Scientific and specialist spinal cord stimulation rival Nevro are also competing.
By Nick Paul Taylor • June 11, 2021 -
Retrieved from C-SPAN on February 23, 2021
HHS warns providers, insurers COVID-19 testing must be free for patients
The American Clinical Laboratory Association, which includes Quest Diagnostics and LabCorp, has complained that guidance on the topic had only served to muddy what they saw as clear congressional mandates.
By Greg Slabodkin • June 10, 2021 -
‘Covid hangover’ to spur health costs to rise 6.5% in 2022, PwC poll predicts
PwC found, however, that a greater reliance on lower-cost sites of care like virtual visits and retail clinics could help offset higher usage of medical services.
By Hailey Mensik • June 9, 2021 -
Justin Sullivan via Getty Images
Amazon offers COVID-19 test online to consumers with a website for viewing results
The tech giant’s coronavirus diagnostic, which received FDA emergency authorization in March, was originally designed for use by company employees but is now available for $39.99 to the public.
By Nick Paul Taylor • Updated June 16, 2021 -
Courtesy of BD/PRNewswire
BD doubles down on COVID-19 testing outlook, despite Abbott warning about demand drop-off
CEO Tom Polen told investors the company stands by its guidance for the rest of the year of $1.8 billion to $1.9 billion in revenue for coronavirus diagnostics, regardless of “anything our competitors have announced.”
By Greg Slabodkin • June 8, 2021 -
National Institute of Allergy and Infectious Diseases. (2020). “Novel Coronavirus SARS-CoV-2” [Micrograph]. Retrieved from Flickr.
OraSure gets EUAs to enter shrinking COVID-19 antigen test market
The technology is differentiated from other rapid antigen tests but is coming to market amid what Abbott characterized as a “sharp and rapid” drop in demand.
By Nick Paul Taylor • June 8, 2021 -
Abbott
Abbott’s COVID-19 testing surprise suggests demand softening faster than sector forecast
The medtech on Tuesday cut its 2021 outlook blaming a sharp, rapid decline in demand for its coronavirus-related tests on vaccinations. The sudden hit to test volumes could be a harbinger for the diagnostics sector.
By Greg Slabodkin • June 2, 2021 -
Courtesy of Abbott
Abbott cuts 2021 outlook, blaming rapid decline in COVID-19 testing demand
CEO Robert Ford described a “sharp and rapid” drop-off in demand, a trend the company expects to continue. Shares slumped 7% on the news.
By Greg Slabodkin • June 1, 2021 -
Analysts tip Edwards’ US TAVR growth at 90% in April
A Jefferies review of hospital data suggests the medtech could comfortably beat the current analyst growth forecast, but comes with multiple caveats.
By Nick Paul Taylor • May 27, 2021 -
Medtronic revenue up 37% as electives make a comeback
CEO Geoff Martha told investors Thursday most businesses are returning to near pre-COVID-19 growth rates, though he admitted there is “work to do” in areas like neurovascular and diabetes.
By Greg Slabodkin • May 27, 2021 -
Courtesy of Abbott, PRNewswire
HHS commits $4.8B to COVID-19 testing for the uninsured
The American Clinical Laboratory Association, with members including LabCorp and Quest Diagnostics, had urged the Biden administration in February to make more money available.
By Susan Kelly • May 26, 2021
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