MedTech Europe sounds alarm over 'inconsistent' enforcement amid flurry of MDR updates

A lack of harmonized standards worries the trade association. Meanwhile, the Medical Device Coordination Group issued new documents on software requirements, implant cards and unique device identifiers.

By Nick Paul Taylor • March 18, 2020

Hologic, LabCorp win emergency use nods as FDA eases rules to boost US coronavirus test volume

In some cases, manufacturers can distribute, and labs can use, new commercially developed tests prior to an emergency use authorization.​ FDA's updated policy also boosts states' authority to greenlight tests.

By Greg Slabodkin • March 17, 2020

Explore the Trendline➔

Top 5 stories from MedTech Dive

From haphazard layoffs at the Food and Drug Administration to the industry’s current IPO environment and tracking FDA-authorized AI devices, here is a collection of top stories from MedTech Dive.

By MedTech Dive staff

To fight coronavirus spread, high-throughput tests bring potential benefits, challenges

Deborah Birx, White House coronavirus response coordinator, said labs will just as importantly need supplies to ramp up testing. The American Clinical Laboratory Association is concerned about potential supply shortages.​    

By Greg Slabodkin • March 15, 2020

Thermo Fisher coronavirus test gets FDA nod

Trump administration officials promised on Sunday that 2,000 labs would be running 1.9 million tests this week. Separately, the American Clinical Laboratory Association expects daily testing capacity to exceed 20,000 next week, with the potential to grow to 280,000 by April 1.  

By Maria Rachal • March 15, 2020

Trump declares national emergency, opening up billions for coronavirus

The president also teased an imminent FDA emergency use authorization for a test from Thermo Fisher, with LabCorp and Quest saying they're collaborating with Roche.

By Samantha Liss • Updated March 13, 2020

Roche is 1st commercial coronavirus test maker to win FDA emergency use authorization

After FDA allowed the company to pre-position its test in the U.S., Roche said it's committed to "going to the limits" of its production capacity to churn out millions of tests per month.

By Maria Rachal • March 13, 2020

Natera breaks ties with Qiagen on NGS testing, citing Illumina deal

The companies teamed up two years ago to develop cell-free DNA assays for a Qiagen reader system, but Thermo Fisher-bound Qiagen later shifted course, which Natera said was a "material breach of the agreement."

By Nick Paul Taylor • March 13, 2020

CDC chief: Reagents critical to coronavirus tests​ 'now are in short supply'

Separately, the government Friday announced funding for development of COVID-19 diagnostic tests from DiaSorin Molecular and Qiagen meant to detect the pathogen in about an hour. 

By Greg Slabodkin • March 13, 2020

FDA chief warns of supply 'pressure' on reagents for coronavirus tests

Qiagen, a major supplier of RNA extraction kits, confirmed to MedTech Dive Thursday that "extraordinary demand for coronavirus testing workflows" is challenging the company's capacity.

By Greg Slabodkin • March 12, 2020

White House, CDC under fire for availability of coronavirus tests

The Trump administration is facing criticism that federal agencies did not engage the big private labs early enough in the public health emergency.

By Greg Slabodkin • March 11, 2020

ECRI: Poor sterilization, failure to learn from device problems threaten patient safety

The 2020 list put together by the nonprofit ECRI Institute also highlights diagnostic errors as a top patient safety concern for a third consecutive year.

By Maria Rachal • March 10, 2020

Labs step up capacity to meet demand for nationwide coronavirus testing

The Trump administration is relying on the "enormous capacity" of commercial labs to enable wide availability of COVID-19 diagnostic testing to the American public through physicians offices and pharmacies. 

By Greg Slabodkin • March 10, 2020

ACC 2020 meeting canceled as coronavirus spreads in US

Abbott, Edwards and Medtronic were among the medtechs slated to present data at the American College of Cardiology's annual event. "This is a unique time for us all," the organization wrote in a statement Monday.

By Maria Rachal • March 9, 2020

$8.3B in coronavirus funding set in motion as federal agencies ramp up response

The House and Senate passed a bill with allocations for medical supplies and testing as Vice President Mike Pence met with clinical lab execs Wednesday from LabCorp, Quest Diagnostics, Thermo Fisher and others.

By Shannon Muchmore • Updated March 5, 2020

LabCorp launches coronavirus test, Quest in the wings

The updates from the major U.S. clinical labs come days after FDA OK'ed the use of lab developed tests that have not yet received emergency use authorization.

By Maria Rachal • March 5, 2020

Insurer lobby urges coronavirus test coverage, but can't mandate changes

“They can’t require member companies to do anything,” said Sabrina Corlette, a research professor at Georgetown University's Center on Health Insurance Reforms.

By Samantha Liss • March 5, 2020

UK looks to use Brexit to make device industry more transparent

The House of Commons bill seeks to address a regulatory gap for medical devices, as the previous legal framework is based on EU directives. One element provides new information-sharing powers related to safety.

By Nick Paul Taylor • March 5, 2020

Exact Sciences closes takeovers of 2 cancer testing businesses

The deals give the diagnostics company a solid tumor test and R&D capabilities as it aims to expand beyond its flagship Cologuard product.

By Nick Paul Taylor • March 4, 2020

After waffling, Qiagen agrees to $11.5B buyout by Thermo Fisher

Months of will-they-won't-they M&A rumors culminated in the Dutch test maker accepting an offer for a 23% premium on its shares, as Thermo Fisher aims to strengthen its molecular diagnostics and infectious disease efforts.

By Maria Rachal • March 3, 2020

FDA seeks 'right balance' as it permits immediate use of coronavirus tests

"We are not changing our standards for issuing Emergency Use Authorizations," Commissioner Stephen Hahn said Saturday as the agency issued new guidance aimed at accelerating testing capacity in the U.S.

By Susan Kelly • March 2, 2020

Coronavirus: No US shortages of essential devices yet, as FDA monitors more than 60 companies

Still, manufacturers operating 72 plants in China face workforce pressures and surging demand for some equipment, FDA said in an update late Thursday.

By Nick Paul Taylor • Feb. 28, 2020

FDA pilots new 510(k) submission template for device manufacturers

The voluntary assessment will enroll up to nine participants that reflect the makeup of the medical device industry.

By Nick Paul Taylor • Feb. 27, 2020

FDA bolsters CLIA waiver application recommendations

The agency added new sections on failure alerts, labeling and safeguards, doubling the length of a guidance text for in vitro diagnostic manufacturers in the process. 

By Nick Paul Taylor • Feb. 26, 2020

Guardant predicts net loss doubling as it takes on Exact Sciences' Cologuard

The cancer testing company's CEO said new studies could open up significant market opportunities, justifying the spending surge.

By Nick Paul Taylor • Feb. 25, 2020

1st test for genetic condition tied to developmental delay wins FDA nod

Austin, Texas-based biotech Asuragen won De Novo authorization for a blood test for Fragile X Syndrome, which the agency said is the most common known cause of inherited developmental delay and intellectual disability.

By Maria Rachal • Feb. 24, 2020