COVID-19: Page 2
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Wavebreakmedia via Getty Images
Masimo’s pulse oximeter has no significant racial bias, study finds
The company said the result reflects its use of four additional signal processing engines that cut the impact of factors including skin pigmentation.
By Nick Paul Taylor • Nov. 28, 2022 -
Mario Tama via Getty Images
‘Tripledemic’ concerns spur FDA to issue emergency authorization for flu-COVID-19 combination test
Experts have warned “a viral hurricane is making landfall” as cases of RSV, influenza and COVID-19 rise simultaneously.
By Nick Paul Taylor • Nov. 23, 2022 -
Adeline Kon/Healthcare Dive/MedTech Dive
Q3 Earnings Wrap: Bumpy time for medtech with inflation, FX, supply woes
Macroeconomic pressures were a persistent theme for the industry, with workforce reductions a part of the fallout for some companies.
By Susan Kelly • Nov. 21, 2022 -
Scott Olson via Getty Images
How Labcorp, Abbott, BD, Siemens plan to expand home testing market
As demand wanes for COVID-19 testing, businesses see an opportunity in direct-to-consumer diagnostics.
By Elise Reuter • Nov. 16, 2022 -
Courtesy of Roche
Roche starts OTC sales of COVID-19 test in first push into US market
CVS, Amazon and the Optum Store are stocking the product, rebranded Pilot.
By Nick Paul Taylor • Nov. 11, 2022 -
Retrieved from Siemsens Website on July 01, 2022
Siemens Healthineers beats sales forecasts on imaging demand as diagnostic pressures prompt restructuring
Siemens Healthineers is revamping its diagnostics unit after concluding that “external headwinds [are] outweighing operational improvements.”
By Nick Paul Taylor • Nov. 9, 2022 -
Courtesy of Hologic
Hologic quarterly sales beat forecast even as demand for COVID tests wanes
The company expects its surgical and breast health businesses to rebound in fiscal 2023.
By Nick Paul Taylor • Nov. 1, 2022 -
Courtesy of Labcorp
Labcorp lowers 2022 forecasts after Q3 profit falls on labor costs, declining COVID-19 revenue
To help reboot earnings, a planned spinoff of the Clinical Development business has been accelerated and the company will continue to acquire testing facilities from hospital systems across the country.
By Peter Green • Oct. 27, 2022 -
Courtesy of Thermo Fisher Scientific
Thermo Fisher raises full-year revenue forecast after posting extra $200M in COVID-19 test sales in Q3
With COVID test sales expected to fall to an “endemic run rate level” in the fourth quarter, the company expects growth to come from the pharma services and bioproduction units.
By Nick Paul Taylor • Oct. 27, 2022 -
Courtesy of Abbott
Abbott Q3 device sales slowed by supply chain pressures; COVID-19 tests exceed expectations
The company raised its earnings forecast for 2022 on the back of an expected $7.8 billion in annual sales related to COVID-19 testing.
By Elise Reuter • Oct. 19, 2022 -
Sarah Silbiger via Getty Images
FDA seeks feedback on plans to draft and finalize medical device guidance in 2023
The agency’s review includes guidance on transitioning away from emergency use authorizations, while abandoning plans for guidance on software as a medical device.
By Nick Paul Taylor • Oct. 19, 2022 -
Joe Raedle / Staff via Getty Images
Avellino, Cepheid, GeneMatrix update COVID-19 test EUAs amid shift in FDA’s approach
COVID-19 test manufacturers have amended their fact sheets to state that diagnostics cleared or approved by the agency should be used instead of their emergency-authorized kits.
By Nick Paul Taylor • Oct. 17, 2022 -
Retrieved from Abbott/PRNewswire on June 15, 2020
Abbott, J&J and Intuitive to lead off medtech earnings season; procedures, supply chain in spotlight
Results from the three companies are expected to shed light on how the economic slowdown is affecting procedure trends in the industry.
By Nick Paul Taylor • Oct. 17, 2022 -
South_agency via Getty Images
Hospital staff shortages spurred drop in TAVR procedures in Q3, surgeon survey shows
Staffing at hospitals is expected to remain disrupted until at least 2024, reducing the number of surgeries, more than 40% of respondents said.
By Nick Paul Taylor • Oct. 14, 2022 -
Retrieved from Jiangsu Well Biotech Co. on October 12, 2022
Jiangsu Well Biotech distributed unapproved COVID-19 tests, FDA says
The company is the latest firm to recall rapid antigen tests that had never received an emergency use authorization or clearance from the regulator.
By Elise Reuter • Oct. 12, 2022 -
Courtesy of Summa Health
Quest agrees to buy Ohio-based health system’s lab-testing business
It’s the latest deal in a string of acquisitions by commercial laboratory companies as hospitals seek to cut costs and improve testing capacity.
By Elise Reuter • Oct. 6, 2022 -
Wavebreakmedia via Getty Images
Pulse oximeter bias delayed treatment of Black COVID-19 patients by hours: study
An author of the paper called for manufacturers to “go back to the drawing board to provide clinicians with a tool that is free from bias.”
By Nick Paul Taylor • Sept. 30, 2022 -
Drew Angerer via Getty Images
FDA switches COVID-19 tests to De Novo, 510(k) pathways, limiting EUAs
The FDA will still review EUA requests from “experienced developers” of tests that meet certain criteria.
By Nick Paul Taylor • Sept. 28, 2022 -
Sarah Silbiger via Getty Images
Puerto Rico-based lab ceases COVID-19 test; FDA revokes EUA
The FDA disclosed the action alongside updates to the instructions for use for Thermo Fisher Scientific’s TaqPath COVID-19 test.
By Nick Paul Taylor • Sept. 26, 2022 -
Wavebreakmedia via Getty Images
Racial bias in pulse oximeters to be subject of FDA panel
The design of the ubiquitous fingertip monitors has inadvertently caused false blood oxygen readings in darker-skinned patients, a problem the FDA hopes to fix.
By Peter Green • Sept. 16, 2022 -
Kevin C. Cox via Getty Images
CDC backs updated COVID shots from Pfizer, Moderna
One day after the FDA’s authorization, the CDC recommended the companies’ omicron-targeted vaccines for most adults and children over 12 years old.
By Delilah Alvarado • Sept. 2, 2022 -
Phil Walter via Getty Images
Another COVID-19 test supplier ordered by FDA to take its products off the market
USA Medical has been warned by FDA that its rapid antigen tests had not been cleared or authorized by the agency.
By Elise Reuter • Sept. 1, 2022 -
Sarah Silbiger via Getty Images
FDA clears updated COVID-19 boosters from Pfizer, Moderna
The new shots, which are designed to better target circulating strains of omicron, could be available within days. Advisers to the CDC are set to meet later this week.
By Delilah Alvarado • Aug. 31, 2022 -
John Moore / Staff via Getty Images
FDA takes N95 respirators off medical device shortage list
Respirators were one of the first medical devices identified as being in critical shortage during the COVID-19 public health emergency, the agency said.
By Ricky Zipp • Aug. 29, 2022 -
Gabriel Kuchta via Getty Images
Moderna sues Pfizer, BioNTech over COVID-19 vaccine technology
The biotech claims its rivals’ vaccine Comirnaty, one of the world’s top-selling pharmaceutical products, infringes on two patents covering its messenger RNA technology.
By Jonathan Gardner • Aug. 26, 2022
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