COVID-19: Page 23
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Jacob Bell
Siemens COVID-19 test gets high marks on FDA sensitivity list, beating Abbott, BD and Roche
A PerkinElmer test still holds the top position among coronavirus diagnostics least likely to return false negatives.
By Nick Paul Taylor • Dec. 4, 2020 -
Danielle Ternes
CDRH headed for 'reset' in 2021 after COVID-19 derailed priorities, Shuren says
After a "massive increase" in work due to the pandemic, the device center anticipates continuing to manage coronavirus projects while also focusing on MDUFA V and new programs.
By Ricky Zipp • Dec. 3, 2020 -
CMS adds hip replacements, other surgeries to ASC list in final rule
A representative from Stryker applauded the changes and said the rule will encourage providers to consider the shift to ambulatory surgery centers.
By Ricky Zipp • Updated Dec. 4, 2020 -
EU underscores remote notified body audit policy amid pandemic
MedTech Europe has pressed the Commission to expand such reviews to the incoming MDR and IVDR regs, but a new Q&A notes the scope is limited to the directives and devices considered "clinically necessary" during the crisis.
By Nick Paul Taylor • Dec. 3, 2020 -
Everlywell raises $175M to expand at-home health testing, virtual care services
The startup was first to win FDA emergency approval for a COVID-19 test self-collection kit. Sales of most tests are growing more than 100% year over year, driven by deals with Target, Walgreens and CVS, though competition is rising.
By Nick Paul Taylor • Dec. 3, 2020 -
Medtechs, working with FDA, offer guidance for remote control of medical devices during pandemic
GE Healthcare, Medtronic, Philips and ResMed are among those that have modified products with such capabilities to create safe physical distance between providers and COVID-19 patients.
By Greg Slabodkin • Dec. 2, 2020 -
Nevro Q4 sales to drop as COVID-19 headwinds stiffen: analysts
If the change in tone reflects growing unwillingness of patients to get elective care as cases surge, as Baird analysts believe, the update could have implications for other medical device companies.
By Nick Paul Taylor • Dec. 1, 2020 -
Fitbit data suggests potential for early COVID-19 detection using wearables
While the algorithm would generate far more false than true positives even when prevalence is high, researchers argue it could encourage more testing and precautions. The results have yet to be validated in a prospective study.
By Nick Paul Taylor • Dec. 1, 2020 -
Getty Images
CMS expands ability for hospital-level care at home ahead of holiday virus spread
Six health systems received waivers to treat more than 60 acute conditions under the new program, which also tweaks earlier changes allowing ambulatory surgical centers to provide greater inpatient care.
By Shannon Muchmore • Nov. 30, 2020 -
Healthcare deals in Q4 predicted to fall from record-setting Q3: report
Market research firm CB Insights believes the drop will carry over into the digital health sector too, an area that's seen historic investor interest in 2020 amid the coronavirus pandemic.
By Rebecca Pifer • Nov. 25, 2020 -
Hospitals adopt new round of elective surgery restrictions, brace for Thanksgiving COVID-19 surge
The American College of Surgeons is among those placing new emphasis on factoring healthcare worker wellbeing into capacity decisions.
By Maria Rachal • Nov. 25, 2020 -
Medtronic ends earnings season with mixed results vs. TAVR rival Edwards
The medtech giant's financials reported Tuesday, with a month more of COVID-19 trends factored in compared to competitors, also show some divergence in the spine and neuromodulation markets.
By Nick Paul Taylor • Nov. 25, 2020 -
Medtronic details diabetes, TAVR offensives as COVID-19 recovery progresses
Q2 data shows how Medtronic's turnabout has been faster than expected, but the company declined to give future guidance because of the global coronavirus resurgence, CEO Geoff Martha said.
By Greg Slabodkin • Nov. 24, 2020 -
MedTech Europe backs proposed EU Health Union but flags potential hangups
The trade group fears moving responsibility for administering the IVDR and MDR expert panels to the European Medicines Agency could slow deployment.
By Nick Paul Taylor • Nov. 20, 2020 -
Notified bodies report early success with remote audits but challenges remain
While there have been benefits to going remote during the pandemic, 57% of those polled by a European trade group say they take longer than on-site assessments and most encounter problems due to poor network connections.
By Nick Paul Taylor • Nov. 20, 2020 -
Alex Wong via Getty Images
HHS piloting Cue's NBA-tested rapid COVID-19 diagnostic in 5 states
Unlike lab-based molecular tests, which can take two to three days to turn around, Cue Health's point-of-care molecular test generates results in about 20 minutes.
By Maria Rachal • Nov. 19, 2020 -
Getty Images
Older patients less willing to have elective procedures as COVID-19 surges: survey
Patient sentiment has deteriorated since September, according to findings from Needham, even as medtech companies have taken steps to encourage a return to care.
By Nick Paul Taylor • Nov. 19, 2020 -
Master Sgt. Hecht, Matt. (2020). [Photograph]. Retrieved from Flickr.
Health insurers, labs point fingers over COVID-19 test coverage and prices
An AHIP study of claims data is the latest volley in a debate about who ultimately foots the bill for coronavirus diagnostics. ACLA blames "murky" tri-agency guidance for coverage denials and high out-of-pocket costs.
By Nick Paul Taylor , Greg Slabodkin • Nov. 19, 2020 -
Hospitals across US cancel elective procedures — again
Although distinct from wholesale shutdowns earlier this year, health systems from Chicago to El Paso are again putting off non-emergency care, which often includes joint replacement surgeries.
By Hailey Mensik • Nov. 18, 2020 -
Jacob Bell
FDA OKs first fully at-home COVID-19 test as US cases surge
An emergency use authorization to biotech Lucira Health comes as some experts say the tests could help significantly boost capacity. Others say that's a long way off, and call for more guidance from regulators on proper use.
By Greg Slabodkin • Nov. 18, 2020 -
"White House Press Briefing". Retrieved from The White House.
In shift, FDA ordered to provide 'timely' EUA reviews for COVID-19 lab developed tests
Testing czar Brett Giroir has reversed FDA's decision to no longer review emergency use authorization requests for LDTs so that university labs can secure EUAs and get liability protection under the PREP Act.
By Greg Slabodkin • Nov. 17, 2020 -
Moderna
Moderna says vaccine prevents COVID-19 in large study, spurring hope for several protective shots
The results are on par with those reported by Pfizer and BioNTech last week, which pressured an array of diagnostics stocks. Shares in antigen test maker Quidel opened down Monday.
By Ben Fidler • Nov. 16, 2020 -
"State Public Health Laboratory in Exton Tests for COVID-19" by Governor Tom Wolf is licensed under CC BY 2.0
Labs face COVID-19 surges, warn of test result delays as CMS pay cuts loom
The American Clinical Laboratory Association sounded an alarm over nationwide capacity constraints, which may increase average time to results.
By Maria Rachal • Nov. 13, 2020 -
National Institute of Allergy and Infectious Diseases. (2020). "Novel coronavirus SARS-CoV-2" [Microscope image]. Retrieved from https://www.flickr.com/photos/nihgov/49535193876/in/album-72157713108522106/.
Quidel on defense after COVID-19 vaccine spurs questions of reduced testing demand
The company's stock has been under pressure following positive vaccine results. CEO Doug Bryant argued Thursday the demand for tests is "endless."
By Greg Slabodkin • Nov. 13, 2020 -
Kendall Davis/Industry Dive/MedTech Dive, data from Marc Nozell
3 ways Biden's COVID-19 approach could impact medtech
A new administration — regardless of who's in power — means device makers can anticipate shifts at key government agencies like the FDA.
By Maria Rachal , Greg Slabodkin • Nov. 12, 2020
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