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

Medtech sector poised for growth as healthcare staffing tops pre-COVID levels: KeyBanc

The analysts are “leaning into increased medtech exposure” after determining that several challenges that have constrained the industry are easing.

By Nick Paul Taylor • April 13, 2023

FDA sets end date for raft of COVID-related shortages that began early in pandemic

Shortages of home-use ventilators and clinical sample concentrators are expected to continue.

By Nick Paul Taylor • March 20, 2023

QuidelOrtho COVID test is first to win FDA nod via premarket review

Special controls instituted by the FDA as part of the De Novo assessment pave the way for other tests to come to market without pandemic-era Emergency Use Authorization.

By Nick Paul Taylor • March 9, 2023

FDA authorizes first at-home flu-COVID-19 combination test days after its developer files for bankruptcy

Lucira filed for bankruptcy protection last week, saying the “protracted” authorization process caused it to miss out on test sales in the 2022 to 2023 flu season.

By Nick Paul Taylor • Feb. 27, 2023

Henry Schein Q4 profit drops, hurt by falling sales of COVID test kits, PPE

Flu and COVID-19 cases increased appointment cancellations and added to staffing shortages in the quarter.

By Nick Paul Taylor • Feb. 17, 2023

Baxter, Abbott, Thermo Fisher among medtech firms cutting jobs on supply issues, slide in testing

"What COVID gave to diagnostics companies, COVID taketh away now that the virus is endemic,” said one analyst.

By Susan Kelly • Updated Feb. 13, 2023

Thermo Fisher cuts additional 230 jobs in California

The job reductions come amid a downturn in demand for COVID-19 tests.

By Susan Kelly • Updated Feb. 10, 2023

Medtech earnings highlights: Easing of macro pressures, accelerated growth in 2023

Still, the latest round of quarterly results show that hospital staffing and supply chain remain a challenge.

By Nick Paul Taylor • Feb. 6, 2023

Quest cuts 2023 COVID tests forecast amid continued slump in demand; Q4 profit plunges

The company performed 1.2 million molecular tests in the fourth quarter, down from 1.9 million in the third quarter and 5.4 million one year ago.

By Nick Paul Taylor • Feb. 3, 2023

FDA weighs shift in COVID vaccination strategy

Agency scientists are proposing to update COVID shots once a year to match circulating coronavirus strains, as well as simplifying current vaccination regimens.

By Ned Pagliarulo • Jan. 23, 2023

Investors hand Vaxxas $23M to support trial of needle-free COVID-19 vaccine

With support from the Gates Foundation, the needle-free technology could get more people vaccinated and avoid cold-chain issues.

By Nick Paul Taylor • Dec. 12, 2022

Excess deaths to continue constraining recovery of TAVR market in 2023: Goldman

Hospital staffing shortages and excess deaths among seniors are expected to slow the recovery of structural heart procedures, Goldman Sachs analysts said. 

By Nick Paul Taylor • Dec. 7, 2022

18M projected to lose Medicaid coverage at end of COVID-19 emergency

Many people who are currently enrolled in Medicaid will transition to other coverage, but 3.8 million people will completely lose insurance, according to the Robert Wood Johnson Foundation.

By Susan Kelly • Dec. 6, 2022

The 10 biggest medtech stories of 2022

MedTech Dive reporting this year has explored how companies maintained momentum even amid supply shortages and rising inflation rates.

By MedTech Dive staff • Dec. 3, 2022