Quidel gets EUA to rival Abbott's rapid, point-of-care antigen test

The pregnancy-like diagnostic is up to five minutes faster than the big medtech's equivalent test and, based on current data, may be more sensitive.

By Nick Paul Taylor • Dec. 22, 2020

Notified bodies warn MDR certification bottleneck could lead to medical device shortages

With more than 7,000 certificates set to expire in 2024, Team-NB wants the European Union to act now by allowing remote audits under the Medical Device Regulation.

By Nick Paul Taylor • Dec. 21, 2020

Medtech's COVID-19 recovery will have to wait for second half of 2021: analysts

Wall Street expects declines in elective care to continue as coronavirus cases keep rising. However, a more widespread rollout of vaccines could spur momentum later in the year.

By Ricky Zipp • Dec. 21, 2020

Moderna's first FDA clearance brings the US a second coronavirus vaccine

The FDA's emergency authorization of the biotech's shot bolsters an immunization campaign in the U.S. that's just beginning.

By Ben Fidler • Dec. 18, 2020

Abbott to supply 30M COVID-19 diagnostics to HHS as Beckman Coulter targets mass testing

The buy comes on top of a $760M purchase of Abbott's point-of-care tests in August. Beckman Coulter is filing for emergency use with FDA.

By Greg Slabodkin • Dec. 18, 2020

Testing demand for Labcorp, Quest robust even as COVID-19 vaccine administration begins

Quest Diagnostics this week raised its outlook for 2020 earnings and revenue on higher-than-expected demand for coronavirus tests. Jefferies analysts see similarly strong demand at LabCorp after checking in with executives.

By Susan Kelly • Dec. 18, 2020

FDA panel endorses Moderna's coronavirus vaccine

A group of independent experts supported use of the biotech's shot, which is likely to receive an emergency authorization from the agency within days. 

By Ned Pagliarulo • Updated Dec. 17, 2020

Hospital costs drove 2019 health spending, CMS analysis finds

Although health system prices grew at a slower rate than a year earlier, non-price factors, which include "the use and intensity of goods and services," grew 4.2%, compared with 1.8% in 2018, the report published in Health Affairs found.

By Hailey Mensik • Dec. 17, 2020

Abbott antigen test gets FDA nod as first at-home, virtually guided COVID-19 diagnostic

BinaxNOW requires a prescription and a telehealth service to take users through collection. However, public health experts question why prescriptions are being required at all for such tests.

By Greg Slabodkin • Dec. 17, 2020

FDA grants EUA for first fully at-home COVID-19 test without a prescription

The rapid antigen test from Australian company Ellume will be available over the counter for people with or without symptoms and delivers results in about 20 minutes.

By Susan Kelly • Dec. 15, 2020

MDR-IVDR bottleneck persists as EU launches 1st Eudamed module

"Very few notified bodies at this moment in time are taking new products on under the old directive, because a medical device doesn't just get certified overnight," an official at Ireland's National Standards Authority said.

By Nicholas Wallace • Dec. 14, 2020

Trump admin defends national stockpile as PPE, equipment shortages persist

"We’re not the Walmart that you can walk into on a daily basis to get your standard needs to treat patients and get PPE. We are a 911 response team," an HHS official said, adding the stockpile hasn't denied a single state request.

By Rebecca Pifer • Dec. 14, 2020

Roche and Siemens COVID-19 antibody tests shine in FDA accuracy roundup

Abbott's tests seemed to perform slightly worse than the best serology assays but comparably to kits from some other leading diagnostic players such as Beckman Coulter. 

By Nick Paul Taylor • Dec. 14, 2020

Trump admin proposes easing HIPAA to foster value-based care, COVID-19 contact tracing

One goal in revamping the privacy regulations was to make information sharing more efficient, especially during health crises like the opioid epidemic and the coronavirus outbreak, according to top health officials. 

By Rebecca Pifer • Dec. 11, 2020

FDA advisers back Pfizer, BioNTech vaccine, clearing way for emergency approval

A panel of independent experts agreed the benefits of vaccination outweigh the risk, convinced by strong data showing the companies' shot to be 95% effective in preventing COVID-19.

By Ned Pagliarulo • Updated Dec. 10, 2020

Edwards plots TAVR comeback even as COVID-19 surge hits harder

"We've seen a fall-off and we felt it globally, but it's probably more predominant in the U.S.," CEO Michael Mussallem said of the impact of some hospitals limiting elective surgeries.

By Ricky Zipp • Dec. 10, 2020

LabCorp gets EUA for first at-home collection COVID-19 test with no prescription

The lab giant is selling the kit through its consumer-focused Pixel website and may expand into retail channels. The agency is hoping the over-the-counter diagnostic will spur more testing.

By Nick Paul Taylor • Dec. 10, 2020

Roche, Thermo Fisher ally with COVID-19 vaccine developers on antibody testing

The companies are working with Moderna and the University of Oxford to quantitatively measure the antibody levels of recipients of the shots.

By Nick Paul Taylor • Dec. 10, 2020

Dexcom lays out strategy to double revenue by 2025, eyes hospitals, new markets

Wall Street analysts called the five-year guidance by the maker of continuous glucose monitors conservative, but investors were not so sure, sending shares down more than 4% on Wednesday.

By Ricky Zipp • Dec. 9, 2020

Qiagen ups outlook, predicts double-digit non-COVID product growth amid analyst skepticism

Wall Street is not yet persuaded the company's post-pandemic future is bright. William Blair analysts said they want to "see some signs of execution on growth in a post-COVID-19 world." 

By Nick Paul Taylor • Dec. 9, 2020

Company of the Year: Abbott

Demand for the diversified medtech's array of coronavirus tests puts it on solid financial ground going into 2021, amid a challenging year for the medical device industry.

By Maria Rachal • Dec. 9, 2020

Executive of the Year: Doug Bryant, Quidel

The veteran of Abbott has been at the helm for nearly 12 years, setting the company up for opportunities when the COVID-19 pandemic hit in early 2020 to leverage its point-of-care antigen testing.

By Greg Slabodkin • Dec. 9, 2020

The MedTech Dive Awards for 2020

From the relentless demand for COVID-19 tests to the pressure on medtechs' traditional business lines, the industry has faced unprecedented market forces this year.

By MedTech Dive Team • Dec. 9, 2020

Hospitals prepare to reveal prices online come Jan. 1

The rule requires hospitals to prepare a list of pricing information for 300 "shoppable services," such as total knee replacements. However, experts question if the data will benefit consumers.

By Samantha Liss • Dec. 8, 2020

Quest gets first FDA nod for at-home collection coronavirus-flu combo test

The lab giant is using Roche’s diagnostic and instrument, which received an emergency use authorization in September, with its own process for testing samples collected by consumers.

By Nick Paul Taylor • Dec. 7, 2020