Lab industry 'alarmed,' says Senate stimulus bill fails to back testing ramp-up

Without $5 billion in assistance, the American Clinical Laboratory Association contends commercial labs are "being set up to perform COVID-19 testing at a loss." A Senate vote could come Monday.

By Greg Slabodkin • Updated March 23, 2020

Direct-to-consumer companies wade into coronavirus testing to fill gap

Everlywell said Monday it planned to donate its store of COVID-19 tests to hospitals, following guidance from FDA warning consumers of fraudulent at-home tests.

By Rebecca Pifer • Updated March 23, 2020

Diagnostic, device makers scrambling as COVID-19 sweeps US

What began as a potential Q1 headwind for medtechs manufacturing in China has quickly turned into a global crisis with unprecedented challenges and opportunities as the sector grapples with the pandemic.

March 20, 2020

Exact Sciences pulls 2020 sales guidance amid coronavirus uncertainty

Shares in the molecular diagnostics company rose 32% Thursday, suggesting investors are betting use of the firm's flagship colorectal cancer screening test will be relatively immune from the pandemic.

By Nick Paul Taylor • March 20, 2020

US won't suspend China tariffs during coronavirus outbreak

The tariffs present a risk and additional cost to medical supply chains as the need for critical products grows urgent. 

By Shefali Kapadia • March 19, 2020

Medtronic pledges '24/7' ventilator production to meet coronavirus demand

The company is aiming to more than double its manufacturing capacity as GE, Getinge, Philips and others outside of healthcare commit to boosting worldwide supply of the potentially lifesaving machines.

By Maria Rachal • March 19, 2020

Abbott latest to get FDA emergency use nod for coronavirus test

It's the seventh medtech to win the agency's emergency use authorization within the last week as the Trump administration attempts to leverage the private sector, including commercial labs, to boost the nation's testing capacity.

By Greg Slabodkin • March 19, 2020

Lessons from Hurricane Maria could aid Baxter's coronavirus operations

The aftermath of the 2017 storm led to serious manufacturing disruptions to Baxter's IV business and prompted it to strengthen its supply network, which CEO Joe Almeida said might be abating challenges with COVID-19 so far.

By Maria Rachal • March 18, 2020

Moody's cuts medtech outlook on coronavirus upheaval

The pandemic is likely to stall significant M&A activity in the sector, the ratings agency predicts.

By Susan Kelly • March 18, 2020

How an 'overwhelmed' Buffalo lab facing coronavirus supply shortage signals nationwide struggles

The Western New York regional public health lab is a microcosm of the insufficient swab and reagent stocks labs face as they attempt to confirm COVID-19 cases and gauge the scope of their region's outbreak.

By Greg Slabodkin • March 18, 2020

Intuitive Surgical among 1st big medtechs to warn of costly pandemic disruptions

Delayed placements and procedures in China and Italy may not have a material impact on the robotic surgery giant, but similar trends in the U.S. and Europe, along with reduced capital spending by hospitals, present a greater threat.

By Maria Rachal • March 17, 2020

As coronavirus roils region, EU device body adamant about steps to hit MDR deadline

The Medical Device Coordination Group acknowledged implementation “has proven to be a very challenging task” but for now appears to be pushing ahead with the planned May start date.

By Nick Paul Taylor • March 17, 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

Hospitals advised to rethink elective procedures, potentially straining device makers

The Surgeon General and American College of Surgeons urged hospitals to "minimize, postpone, or cancel" certain procedures while handling the COVID-19 outbreak, presenting at least a temporary risk to medtechs' revenue.

By Amritpal Sandhu-Longoria, Maria Rachal • March 16, 2020

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

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

As US officials shift tone on coronavirus, Trump stops short of 1 provider ask

The president did not declare a disaster or national emergency, which groups like the American Hospital Association had sought.

By Samantha Liss , Shannon Muchmore • March 12, 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

Key EU notified body meeting goes on, virtually

A Medical Device Coordination Group meeting, parts of which are postponed, comes as Germany, home to four of 11 notified bodies designated under EU MDR, anticipates widespread COVID-19 transmission.

By Nick Paul Taylor , Maria Rachal • March 11, 2020

Coronavirus spread prompts FDA to postpone nearly all overseas inspections

The agency based the decision on U.S. government travel restrictions and advisories, saying "alternative tools and methods" will help maintain oversight.

By Jonathan Gardner • March 10, 2020

Hospitals dipping into emergency stocks to combat coronavirus

As more community spread of COVID-19 is reported daily, hospitals are bracing for a rush of patients and payers are waiving fees for telemedicine consults and extra prescription drug supplies.

By Shannon Muchmore • March 10, 2020