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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Ending 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

Intuitive posted 26% jump in robotic procedures in Q1 as hospitals chipped away at backlog

The company experienced “some backlog effect from patients generally returning to more normalized healthcare routines, given the effect of the pandemic over several years.”

By Nick Paul Taylor • April 19, 2023