Biden health officials defend COVID-19 testing policies amid diagnostics shortage

Acting FDA Commissioner Janet Woodcock and others were under fire from senators during a Tuesday hearing for not doing enough to increase the availability of tests.   

By Greg Slabodkin • Jan. 12, 2022

FDA seeks feedback on draft device shortage guidance

A new document poses a series of questions for industry on the overall design and operation of the policy, and is intended to help manufacturers provide timely information about supply disruptions during public health emergencies.

By Nick Paul Taylor • Jan. 12, 2022

Edwards seen falling short in Q4 based on early US TAVR volume data: Jefferies

Based on partial data for October and November, the analysts expect U.S. fourth-quarter TAVR sales to grow 7%, compared to a 14% consensus estimate.

By Nick Paul Taylor • Jan. 11, 2022

Insurers will be required to cover 8 at-home COVID-19 tests per month

After proposing the plan in December, the Biden administration on Monday detailed its plan to have insurers cover rapid tests. Health insurance lobby AHIP warned of potential "hiccups in early days" of implementation.

By Nick Paul Taylor • Jan. 11, 2022

Hologic tops guidance as COVID-19 testing wave delivers another beat

The test maker said it will comfortably beat first-quarter guidance, with demand for coronavirus diagnostics helping the company post preliminary revenues of almost $1.5 billion. Quidel set the tone last week with its own beat. 

By Nick Paul Taylor • Jan. 10, 2022

Medtronic CEO: Company on track to hit guidance, omicron impact 'uncertain'

Geoff Martha, who spoke on the opening day of J.P. Morgan's healthcare conference, said the medtech is being impacted by both the delta and omicron variants, including ongoing pressure from hospital staffing shortages.

By Ricky Zipp • Jan. 10, 2022

Quidel preliminary Q4 revenue beats Street on COVID-19 test sales

Fourth-quarter revenue was more than 35% above the consensus analyst estimate, though it was still down from Quidel's 2020 strong final quarter.

By Nick Paul Taylor • Jan. 7, 2022

Wall Street backs Stryker-Vocera strategic fit but split on valuation

The nearly $3 billion buy values Vocera at about 11.5 times higher than expected 2022 revenue, leading some analysts to question the overall price.

By Ricky Zipp • Updated Jan. 7, 2022

Abbott, Quidel COVID-19 antigen tests found to lag PCR in detection of omicron

A small real-world study, which has yet to be peer reviewed, found the rapid tests may fail to detect some omicron cases during the first days of infection.

By Nick Paul Taylor • Jan. 6, 2022

Quest's COVID-19 test results turnaround hits longest wait since 2020

The lab giant is taking an average of two to three days to deliver results for molecular diagnostic tests amid the omicron surge, compared to the one-day turnaround time it achieved throughout most of 2021.

By Nick Paul Taylor • Jan. 6, 2022

Medtechs brace for hit as hospitals warn of omicron impact on surgeries

Healthcare staff shortages and rising COVID-19 admissions are forcing hospitals to cancel elective surgeries and postpone diagnostic and imaging procedures. BTIG sees as much as a 7% revenue hit for exposed companies.

By Nick Paul Taylor • Jan. 5, 2022

Medtech's biggest deals in 2021 and what to expect next

After dealmaking took off last year following a 2020 lull, market watchers anticipate robust M&A ahead in 2022 as companies pursue faster growth and greater scale. 

By Susan Kelly • Jan. 4, 2022

Roche, Siemens at-home tests get EUAs as US faces COVID-19 testing shortage

FDA granted emergency use authorizations to the over-the-counter diagnostics under a new accelerated review program. However, the companies may need months to scale up production.

By Nick Paul Taylor • Jan. 4, 2022

User growth, product delays and a Super Bowl ad: Diabetes tech heads into 2022 after another eventful year

Diabetes tech companies are heading into 2022 with momentum as insulin pump and CGM use climbs and with key product launches on the horizon. Here are MedTech Dive's top sector stories in 2021.

Dec. 28, 2021

Quidel to buy Ortho Clinical Diagnostics in $6B deal; stock tanks

CEO Doug Bryant said the combined company will have a "broader geographic footprint" thanks to Ortho's reach across 130-plus countries. Quidel's shares fell by as much as 17.8% in Thursday morning trading.

By Greg Slabodkin • Dec. 23, 2021

FDA seeks feedback on 180-day notice period for termination of COVID-19 EUAs

The agency's plan is intended to avoid supply disruptions while moving back toward the regulatory requirements of routine operations.

By Nick Paul Taylor • Dec. 23, 2021

Hospitals clamp down on elective surgeries as COVID-19 surges

Cleveland Clinic, Banner Health and other hospital systems are pausing nonessential procedures, while provider groups issued a joint statement Friday declaring that doctors and nurses are exhausted and heartbroken.

By Susan Kelly • Dec. 22, 2021

CDRH warns review timelines will remain extended in 2022 as pandemic pressures continue

The FDA's Center for Devices and Radiological Health expects "a gradual transition back toward normal review timelines" next year as COVID-19 has delayed traditional work.

By Nick Paul Taylor • Dec. 22, 2021

Biden stresses need for additional testing supply, plans to distribute 500M free rapid COVID-19 tests

"We have to do more. We have to do better — and we will," President Joe Biden acknowledged on Tuesday, as a surge in omicron cases has put added stress on America's already strained test supply.

By Greg Slabodkin • Updated Dec. 22, 2021

Most COVID-19 medical device EUAs lack documented supporting data: JAMA

The use of "low-quality data" is reasonable at the start of a crisis but FDA should consider raising the standard of evidence after multiple products come to market, according to the authors of the study.

By Nick Paul Taylor • Dec. 21, 2021

At an 'inflection point,' Smith & Nephew predicts faster growth will follow current challenges

CFO Anne-Françoise Nesmes said there is a procedure backlog from COVID-19 but added that the "new variants of COVID are a reminder of how difficult it is to predict the timing of the recovery."

By Nick Paul Taylor • Dec. 20, 2021

J&J device chief on company split, omicron surge, robotic surgery

Ashley McEvoy is confident that 2022 will not be as bad as the first or second year of the COVID-19 pandemic, even as the omicron variant drives cases up, but adds that "we're not out of the woods yet."

By Ricky Zipp • Dec. 20, 2021

Roundup: Omicron variant's impact on COVID-19 tests

As the variant of concern continues to spread worldwide, FDA and test makers have scrambled to assess whether the performance of diagnostics are affected by omicron's viral mutations. Here's what we know so far.  

Updated Dec. 29, 2021

Federal COVID-19 aid fueled huge jump in national health spending last year

The pandemic accounted for major changes in who paid for healthcare as job losses spurred changes in coverage types, while people deferred care and spent less out of their own pockets.

By Shannon Muchmore • Dec. 16, 2021

FDA in update says 2 COVID-19 tests fail to detect the omicron variant

Diagnostics from Applied DNA Sciences and Meridian Bioscience are not able to detect omicron, causing false negative results, according to the agency, while Tide Laboratories has fixed the problem with its test.

By Greg Slabodkin • Updated Dec. 29, 2021