COVID-19
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Courtesy of Cue Health Press Kit
FDA labels Cue’s recall of COVID tests as Class II, revokes EUAs
Cue Health began the recall of nearly 250,000 COVID-19 test kits in May, shortly after the FDA advised people at home and healthcare professionals not to use the products.
By Nick Paul Taylor • Oct. 17, 2024 -
National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Micrograph]. Retrieved from Flickr.
Routine lab tests fail to detect long COVID in 10,000-person study
Even people with highly symptomatic long COVID may have “no clinically observable objective findings on routine laboratory testing,” according to a study published by the Annals of Internal Medicine.
By Nick Paul Taylor • Aug. 16, 2024 -
Courtesy of Cue Health Press Kit
FDA advises against using Cue Health COVID-19 tests, sends warning letter
Agency inspectors found Cue made unauthorized changes to its COVID-19 kits that “reduced the reliability of the tests.”
By Nick Paul Taylor • May 14, 2024 -
Courtesy of QuidelOrtho
QuidelOrtho names ex-Abbott exec Brian Blaser as CEO
Blaser is coming out of retirement to take charge of QuidelOrtho, after the diagnostics company fired former CEO Doug Bryant in February.
By Nick Paul Taylor • May 3, 2024 -
Courtesy of Cue Health Press Kit
Cue Health to cut 230 employees
Declining COVID-19 test sales have forced Cue to eliminate hundreds of jobs in multiple rounds of layoffs over the past several years.
By Elise Reuter • May 3, 2024 -
Courtesy of Siemens Healthineers
Siemens Healthineers to close fast track diagnostics unit, lay off about 90 workers
Demand for the products peaked during the COVID-19 pandemic but has fallen away since then.
By Nick Paul Taylor • March 19, 2024 -
Courtesy of Cue Health Press Kit
Cue Health axes more jobs amid declining test sales
The company cut 94 workers at the beginning of last month and another 151 people on Jan. 25.
By Elise Reuter • Feb. 9, 2024 -
Wavebreakmedia via Getty Images
FDA panel recommends new standards for pulse oximeters amid bias concerns
Studies have found that pulse oximeters overestimated oxygen saturation in people with dark skin pigmentation, resulting in delayed care.
By Elise Reuter • Feb. 5, 2024 -
Mario Tama via Getty Images
3 bellwether companies to watch as medtech earnings season begins
J&J, Intuitive Surgical and Abbott kick off this week with fourth-quarter reports.
By Nick Paul Taylor • Jan. 22, 2024 -
Courtesy of Roche
Roche to buy LumiraDx’s point-of-care technology for $295M
LumiraDx faces financial pressures amid declining test sales and a potential delisting from the Nasdaq.
By Elise Reuter • Jan. 2, 2024 -
Phil Walter via Getty Images
Acon receives first FDA clearance for over-the-counter COVID-19 antigen test
The FDA is encouraging manufacturers to transition to traditional review pathways now that the acute phase of the COVID-19 crisis is over.
By Nick Paul Taylor • Nov. 10, 2023 -
Wavebreakmedia via Getty Images
25 attorneys general urge FDA to act fast to mitigate risk of racial bias in pulse oximetry
The AGs want the FDA to “require manufacturers and vendors of pulse oximeters to include clear, comprehensible and evidence-based warning labels.”
By Nick Paul Taylor • Nov. 7, 2023 -
Retrieved from Google on May 28, 2020
Elective procedure interest still topping pre-COVID levels, survey finds
Google searches for 20 elective surgeries in the U.S. were at 112% of pre-COVID levels in the week ended Oct. 28, according to a report from Needham analysts.
By Susan Kelly • Nov. 3, 2023 -
Courtesy of Abcam
Danaher Q3 revenue declines as demand challenges continue
Better-than-expected respiratory testing revenue was a bright spot, but the company’s overall orders are “bouncing along” at a bottom, CEO Rainer Blair said on a Tuesday earnings call.
By Susan Kelly • Oct. 24, 2023 -
Scott Olson via Getty Images
US trade commission explores impact of patent rules on COVID diagnostics
The USITC report presents conflicting testimony from the medtech industry and advocacy groups about the impact of compulsory licensing.
By Nick Paul Taylor • Oct. 23, 2023 -
Sarah Silbiger via Getty Images
FDA approves updated COVID boosters from Pfizer, Moderna
Pfizer and Moderna, which have seen slowing demand for their coronavirus vaccines, expect to make the reformulated shots available in the U.S. in the coming days.
By Delilah Alvarado • Sept. 11, 2023 -
Courtesy of Cue Health Press Kit
Cue Health board pressured by investor to review strategy, cut costs
Tarsadia Investments called for the board to “take immediate action to prevent further destruction of stockholder value.”
By Nick Paul Taylor • Sept. 6, 2023 -
Courtesy of Cue Health Press Kit
Cue Health wins $28M BARDA contract to develop rapid respiratory infection test
The company plans to launch the respiratory panel for the 2024-25 virus season and aims to break even in 2025.
By Nick Paul Taylor • Aug. 14, 2023 -
Retrieved from Siemsens Website on July 01, 2022
Varian logistics slow growth at Siemens Healthineers in Q3
Healthineers has worked through some logistics problems but now faces a race to install Varian equipment at customer sites.
By Nick Paul Taylor • Aug. 2, 2023 -
National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Micrograph]. Retrieved from Flickr.
Demand for 4-in-1 test helps Danaher’s COVID sales beat internal forecast
Danaher said it is continuing to take market share as many customers look to consolidate their point-of-care PCR testing platforms.
By Nick Paul Taylor • July 26, 2023 -
glegorly via Getty Images
Interest in elective surgeries up 115% over pre-COVID levels, Google searches show: Needham
The rise in searches correlates with an increase in the size of the market for elective procedures, Needham analysts report, signaling better times for medtech companies.
By Elise Reuter • June 15, 2023 -
Courtesy of Cue Health Press Kit
Cue Health wins first non-emergency authorization for COVID test, days after Goldman downgrade
The FDA’s marketing authorization for Cue’s COVID-19 molecular test could boost consumer access, but the company faces strong competition from more established diagnostic firms.
By Peter Green • June 7, 2023 -
Courtesy of Cue Health Press Kit
Cue Health’s inability to find post-COVID markets for testing prompts Goldman downgrade
The analysts warned switching to non-COVID-19 tests will mean entering a competitive market “where larger companies with financial resources have an established installed base.”
By Nick Paul Taylor • June 5, 2023 -
Drew Angerer/Getty Images via Getty Images
CDC Director Walensky to step down in June
Rachel Walensky, who has served as director since 2001, was criticized for the federal government’s handing of the pandemic, announcing in August last year that she planned to reorganize the CDC.
By Sydney Halleman • May 5, 2023 -
Dragan991 via Getty Images
OpinionEnding free COVID tests risks worsening the pandemic
If Americans start paying out of pocket for COVID tests, they'll test much less — if at all, argue representatives of the Testing at Home Coalition.
By Amy Kelbick and Eric Zimmerman • April 20, 2023
