Biden orders private health insurers to cover COVID-19 home tests

Test makers such as Abbott, BD and Quidel could see demand increase as costs for consumers are reimbursable. The White House is also doubling distribution of free at-home tests to uninsured and underserved communities.

By Nick Paul Taylor • Dec. 3, 2021

FDA finds 'low likelihood' omicron will impact COVID-19 PCR, antigen tests

The agency joined the chorus of top testing manufacturers, including Abbott Laboratories, Quidel and Thermo Fisher Scientific, claiming that current coronavirus diagnostics can accurately identify the omicron variant.

By Nick Paul Taylor • Dec. 1, 2021

Vaccine makers move quickly to confront omicron threat

Several companies, including Pfizer and Moderna, are already at work adapting their coronavirus shots to the newly identified variant, which experts worry could more readily evade vaccine protection.

By Ned Pagliarulo • Nov. 29, 2021

Abbott, BD join chorus of COVID-19 test makers claiming diagnostics not impacted by omicron variant

Becton Dickinson on Tuesday became the latest testing manufacturer to express confidence that both its rapid antigen and PCR tests will detect the variant, which the World Health Organization says poses a "very high" risk.   

By Greg Slabodkin • Updated Nov. 30, 2021

BD test, others among rapid antigen kits authorized for one-time use by FDA

The agency has authorized another three over-the-counter COVID-19 antigen home tests for single use in people with symptoms, furthering the emergence of the kits as an alternative to PCR.

By Nick Paul Taylor • Nov. 29, 2021

Biden admin investing $1.5B to quell healthcare staffing shortages, promote workforce equity

The funding is meant to address staffing shortages that have been exacerbated by the pandemic and impacted the entire healthcare industry, from hospitals to medical device companies.

By Hailey Mensik • Nov. 24, 2021

4 takeaways from Medtronic's latest earnings report

The medtech giant on Tuesday discussed a wide range of issues impacting the company, from whether procedure volumes rebounded in November to the chances of it spinning off non-core or underperforming business units.

By Nick Paul Taylor • Nov. 24, 2021

Roundup: COVID-19 surge, hospital labor shortages, supply chain issues hit medtechs in latest earnings

After the industry began recovering in the first half of the year, top companies reported that the delta variant surge put a drag on businesses last quarter.

Nov. 23, 2021

Medtronic blames revenue miss on COVID-19 resurgence, hospital staffing shortages

CEO Geoff Martha said the medtech was hit in its second quarter by pandemic-related challenges that weighed on procedure volumes, particularly in the U.S.

By Greg Slabodkin • Nov. 23, 2021

FDA resumes domestic surveillance inspections as omicron cases decline

The regulator has restarted the examinations, following a six-week freeze in response to the variant's surge. FDA plans to conduct foreign prioritized inspections starting in April.

By Nick Paul Taylor • Updated Feb. 7, 2022

FDA, aiming to curb another COVID-19 surge, clears Pfizer, Moderna boosters for all adults

The decision comes as at least 10 states have already begun opening up booster dose eligibility, with cases remaining at high levels across the country. 

By Ben Fidler • Nov. 19, 2021

30% of hospital healthcare workers remained unvaccinated as of September

Healthcare workers in children's hospitals had the highest vaccination rates, along with those working in metropolitan counties, according to the analysis of Centers for Disease Control and Prevention data.

By Hailey Mensik • Nov. 18, 2021

Siemens Healthineers projects revenue jump fueled by Varian double-digit sales growth

The medtech expects its $16.4 billion Varian acquisition to post annual sales growth from 2023 to 2025, leading it to forecast accelerating revenue rises.

By Nick Paul Taylor • Nov. 17, 2021

FDA to regulate lab developed tests in policy reversal

HHS is withdrawing a Trump-era policy that exempted LDTs from premarket review. The American Clinical Laboratory Association warned continually shifting policies "undermines patient access to lifesaving diagnostics."

By Susan Kelly • Nov. 16, 2021

BD's $2B annual M&A war chest, connected care devices at heart of growth plan

Evercore ISI analysts said the targets and messaging were consistent with expectations, while J.P. Morgan questioned why it is taking BD longer than its peers to return margins to pre-pandemic levels.

By Nick Paul Taylor • Nov. 15, 2021

After another successful quarter, diabetes tech players look ahead to key product launches

Dexcom's new G7 CGM system is expected to gain CE mark clearance in Q4, and Insulet's Omnipod 5 insulin pump is on track for FDA clearance and a limited launch by the end of the year.

By Ricky Zipp • Nov. 11, 2021

Medtech sounds alarm on semiconductor shortages, asks feds to prioritize chips for medical use

AdvaMed and several device companies, including BD, Medtronic and Philips, have reiterated to the Biden administration how supply chain constraints are causing an "unsustainable" disruption to the industry.

By Nick Paul Taylor • Nov. 10, 2021

iRhythm's COVID-19 pressures add to Medicare pricing saga

New CEO Quentin Blackford told investors "significant" customer staffing issues are likely to drag on through Q4, limiting the company's capacity and forcing it to lower 2021 guidance.

By Ricky Zipp • Nov. 5, 2021

Stryker, Zimmer, Smith & Nephew warn orthopaedic headwinds to last into Q4

Third-quarter results reveal how the industry remains constrained by COVID-19, hospital staffing shortages and lower pricing in China. 

By Nick Paul Taylor • Nov. 5, 2021

Why are women more likely to use telehealth?

As Washington mulls over telehealth regulations post-COVID-19, it's important not to roll back access in a way that could disproportionately affect women, experts say.

By Rebecca Pifer • Nov. 3, 2021

CMS reinstates Medicare's inpatient-only list in final rule, reversing Trump-era nix

Medtronic, Johnson & Johnson, Stryker and Zimmer Biomet overwhelmingly supported restoring the IPO list in public comments to the July proposed rule. The backing comes as the industry also embraces outpatient care.

By Ricky Zipp • Nov. 3, 2021

Thermo Fisher, Hologic ride wave of COVID-19 test demand, for now

The two lateral flow assay companies reported strong coronavirus testing sales in the latest quarter. However, Hologic CFO Karleen Oberton told investors late Monday the pandemic remains unpredictable.

By Greg Slabodkin • Nov. 2, 2021

3 trends dragging medtechs: Supply chain constraints, inflation and hospital staffing shortages

J&J, ResMed and Stryker are among the companies citing one of these factors as constraining growth in the current reporting season.

By Nick Paul Taylor • Nov. 1, 2021

What does J&J's Ottava delay mean for Intuitive and Medtronic? It's complicated.

The setback doesn't remove hurdles the rivals face playing catch-up to market leader Intuitive's da Vinci, which has a two-decade head start. 

By Ricky Zipp • Oct. 28, 2021

Edwards TAVR volumes tepid in October, quashing hopes of fast recovery from delta

"We didn't want to send a signal that all of a sudden October is back to the kind of thing that we were experiencing in Q2. We're not experiencing that kind of an environment yet," CEO Mike Mussallem told investors Wednesday.

By Nick Paul Taylor • Oct. 28, 2021