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

HIMSS20 canceled over coronavirus concerns

"Cancellation is unavoidable in order to meet HIMSS' obligation to protect the health and safety of the global HIMSS community," conference organizers told vendors Thursday.

By Rebecca Pifer • March 5, 2020

Hospitals face worries of supply, staff shortages as coronavirus cases tick up

FDA granted a CDC request late Monday for an emergency use authorization that will allow respirators typically used in industrial settings, including N95 masks, to be used in healthcare facilities during the outbreak.

By Shannon Muchmore • March 3, 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

HHS officials warn of medical supply shortages amid coronavirus outbreak

"This is an unprecedented potential severe health challenge globally, and will require additional measures," HHS Secretary Alex Azar told lawmakers in a pitch for $2.5 billion in funding.

By Amritpal Sandhu-Longoria • Feb. 26, 2020

Teleflex strikes $260M deal, gaining parts used in TAVR procedures

In releasing quarterly results, the Wayne, Pennsylvania-based medtech also gave updates on a new direct-to-consumer ad campaign and headwinds expected from the coronavirus outbreak.

By Nick Paul Taylor • Feb. 20, 2020

Medtronic misses revenue estimates as TAVR position falters

A disappointing quarter for the medtech giant, with particular softness across pain therapies and cardiac rhythm and heart failure, sent shares down nearly 4% in morning trading Tuesday.

By Maria Rachal • Feb. 18, 2020

FDA tracks uptick in masks, other protective gear in coronavirus update

Commissioner Stephen Hahn said the shift in ordering patterns is yet to manifest in a shortage but warned Friday the situation is “evolving and very dynamic.”

By Nick Paul Taylor • Feb. 18, 2020

Moody's: Coronavirus spread in US to have mixed credit effects across healthcare

Device makers — particularly Boston Scientific, BD and Abbott — will likely see a credit negative effect from supply chain disruption, even if the outbreak is contained to China.

By Shannon Muchmore • Feb. 13, 2020

Snapshot: How medtech earnings season is shaping up

Most medtechs offered financial outlooks for 2020 over the last month, but the novel coronavirus could have a longer impact than originally factored in.  

By Maria Rachal • Updated March 6, 2020

BD cuts 2020 guidance on Alaris pump hangup with FDA, stock tanks

"Resetting expectations is certainly not how I want to start my first call as CEO," new BD head Tom Polen told analysts. Shares were down as much as 13% Thursday morning.

By Maria Rachal • Feb. 6, 2020

Boston Scientific expects up to $40M hit in Q1 from coronavirus

Ongoing integration of its $4.2 billion acquisition of BTG and pricing headwinds for drug-eluting stents may also temper growth, the company said on its earnings call Wednesday.

By Maria Rachal • Feb. 5, 2020

Qiagen, still independent, limps back from 2019

The Dutch maker of infectious disease instruments and consumables is seeking a rebound, with an early boost from coronavirus-driven demand. Cowen analysts noted the firm beat expectations but added: "The bar was quite low."

By Nick Paul Taylor • Feb. 5, 2020

Emergency use coronavirus tests shows glitches at state level, CDC says

CDC officials said Wednesday that some of the test kits it distributed to states produced inconclusive results when tested independently. The agency noted the tests were not run on patients.

By Maria Rachal • Updated Feb. 13, 2020

Amid coronavirus outbreak, FDA and industry seek roadmap for emergency diagnostics

Taking lessons from the Ebola and Zika crises, regulators and manufacturers are meeting Monday to discuss how real-world data could be used to advance more emergency-use diagnostics to full marketing status.

By Maria Rachal • Updated Jan. 31, 2020

CDC urgently working to make coronavirus lab diagnostic available

A Centers for Disease Control and Prevention official told reporters the agency is in the process of growing the virus for further study and working to get laboratory diagnostics to state and local health departments.

By Shannon Muchmore • Jan. 27, 2020

Feds team up to speed diagnostic testing access in emergencies

Labs using an in vitro diagnostic granted an Emergency Use Authorization must still comply with Clinical Laboratory Improvement Amendments regulations.  

By David Lim • Feb. 27, 2019