COVID-19: Page 3
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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 -
iStock / Getty Images Plus via Getty Images
Medical device industry poised to withstand an economic slowdown, experts say
While procedures volumes may decline, analysts said the effects likely won’t reach levels seen in 2020 or during the Great Recession.
By Ricky Zipp • Aug. 22, 2022 -
Permission granted by ResMed
Q&AFriday Q&A: ResMed CEO Mick Farrell discusses Philips recall, improving supply chain, prioritizing patients
The executive spoke about managing a 12-month patient backlog following a spike in demand due to Philips’ recall and supply constraints.
By Ricky Zipp • Aug. 19, 2022 -
Sarah Silbiger via Getty Images
Medical device recalls hit two-year high in Q2, report finds
While the number of recalls jumped in the period, the total units affected dropped to the lowest point in five years.
By Ricky Zipp • Aug. 18, 2022 -
Courtesy of Insulet Corp.
Insulet raises forecast as Omnipod 5 sales climb; Tandem expects tougher market in second half
Both insulin pump companies grew revenue by more than 10% in the second quarter, but Tandem lowered its 2022 forecast amid a tougher market, while Insulet increased its guidance.
By Ricky Zipp • Aug. 11, 2022 -
Spencer Platt/Getty Images via Getty Images
Roundup: Medical device industry confident it can ride out recession, wary of slowing capital sales
While companies may weather a recession, they still face challenges like hospital staffing shortages, supply chain disruption and inflation, RBC Capital Markets analysts wrote.
By Nick Paul Taylor • Updated Aug. 10, 2022 -
Peter S Green/MedTech Dive
QuidelOrtho reports 37.5% sales growth in first quarter since $6B merger
The testing firm is increasing sales after Quidel merged with Ortho, opening opportunities to cut costs and increase point-of-care and molecular diagnostics revenue.
By Nick Paul Taylor • Aug. 5, 2022 -
Permission granted by Becton Dickinson
BD’s base business growth in Q3 offset by drop in COVID-19 testing
The company reported a year-over-year drop of about $224 million in COVID-19 testing revenue compared to 2021, with the testing slowdown expected to continue.
By Ricky Zipp • Aug. 4, 2022 -
Retrieved from Siemsens Website on July 01, 2022
Siemens Healthineers stumbles as lockdowns, falling COVID-19 sales and rising costs hit business
Lockdowns in China caused a steep decline in equipment orders and a big setback to the firm’s core diagnostic business, even as the company expects to meet full year revenue targets.
By Nick Paul Taylor • Aug. 3, 2022 -
Ethan Miller via Getty Images
North American Diagnostics latest to recall COVID-19 tests, gets Class I label from FDA
The recall adds to a list of medtech firms that have been forced to withdraw illegally distributed COVID-19 tests, amid concerns they could yield false results.
By Ricky Zipp • Aug. 2, 2022 -
Retrieved from Medridien Bioscience website on August 01, 2022
FDA reauthorizes Meridian’s COVID-19 test after changes to enable omicron detection
The renewed emergency use authorization comes as SD Biosensor works to close its $1.53 billion takeover of Meridian.
By Nick Paul Taylor • Aug. 1, 2022
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