Boston Scientific sees April sales cut in half amid coronavirus

One potential area of optimism: two-thirds of the device giant's business comes from procedures in outpatient settings like ambulatory surgery centers and physicians offices, which the company expects will resume operations sooner.

By Maria Rachal • April 29, 2020

GE reducing healthcare headcount in $700M cost-cutting drive

The cuts come as the conglomerate seeks to adapt its business to volatility and pressures created by the global coronavirus pandemic.

By Nick Paul Taylor • April 29, 2020

LabCorp pulls 2020 guidance as testing demand plunges due to COVID-19

CEO Adam Schechter told investors that increasing capacity for coronavirus antibody and molecular tests will likely offset some of the volume shortfall, but that small slice of its business isn't enough to "make up for the difference."  

By Greg Slabodkin • April 29, 2020

LabCorp, Quest expand COVID-19 antibody testing nationwide

Amid the moves by the giant commercial labs, a White House plan released Monday says the administration is still exploring how to improve the reliability of these products.

By Greg Slabodkin • April 28, 2020

FDA encourages remote review of digital pathology slides amid COVID-19

The agency's latest effort to support greater access to medical devices during the pandemic follows a move by CMS that opened the door for pathologists to work away from the lab.

By Susan Kelly • April 27, 2020

Gottlieb, Slavitt pitch $46.5B plan for COVID-19 contact tracing, isolation

Primary care doctors should be the main referral source for testing and contact tracing, according to a letter penned by a bipartisan group including former CMS head Andy Slavitt and former FDA Commissioner Scott Gottlieb.

By Shannon Muchmore • April 27, 2020

Abbott, DiaSorin coronavirus antibody tests get EUAs as lawmakers question others on market

As more diagnostics assessing possible immunity to the virus win FDA emergency use authorization, criticism is mounting over the accuracy of products the agency allowed on the market without the designation.

By Greg Slabodkin • April 27, 2020

It's official: EU finalizes 1-year MDR delay

The European Commission listed a 13th notified body designated for Medical Device Regulation-related work in its official database Saturday, the first new firm announced in over a month and the fifth based in Germany.

By Maria Rachal • Updated April 27, 2020

FDA moves to boost access to imaging systems during pandemic

The agency is allowing devices to be modified for portable use to enable imaging outside of hospitals in an effort to potentially slow the spread of COVID-19. 

By Nick Paul Taylor • April 24, 2020

FDA OKs updated instructions for Abbott POC coronavirus test amid accuracy concerns

The company's update comes as some providers raise red flags. The Cleveland Clinic compared five COVID-19 testing platforms and found Abbott's point-of-care test had a higher false negative rate than some counterparts. 

By Maria Rachal • April 23, 2020

MedTech Europe pushes for IVDR delay as MDR hold nears finish line

The trade group warned that "even before the COVID-19 pandemic, very little progress had been achieved" to get the In Vitro Diagnostic Regulation ready, which it said altogether warrants at least a 12-month delay.

By Nick Paul Taylor • April 23, 2020

Thermo Fisher and Roche enjoy COVID-19 diagnostic tailwinds, but warn of routine testing declines

Both companies disclosed big hits to business in China during first quarter earnings calls Wednesday, indicating negative impacts in the U.S. and Europe could be more apparent on second quarter balance sheets.

By Nick Paul Taylor • April 22, 2020

Medtronic sees US business fall 60% amid pandemic response

The subset of devices suddenly seeing higher demand are mostly low-margin businesses, leading the medtech giant to brace investors for a hit to earnings during next month's quarterly report.​

By Maria Rachal • April 22, 2020

Quest Diagnostics testing volumes plunge due to coronavirus

"We're definitely living in extraordinary times," CEO Steve Rusckowski told investors Wednesday, reporting a decline by more than 40% during the last two weeks of March.

By Greg Slabodkin • April 22, 2020

COVID-19 bill with $25B for lab testing signed into law

The clinical lab lobby praised the legislation, which includes funds for serology and molecular testing.

By Shannon Muchmore • Updated April 24, 2020

As COVID-19 antibody tests proliferate, analysts see market worth billions for Abbott, Roche and others

Initial serology testing for U.S. healthcare workers alone could represent a $65 million opportunity, Cowen estimated in a report released Tuesday.

By Susan Kelly • April 21, 2020

LabCorp coronavirus test gets 1st FDA nod for at-home sample collection

The agency re-issued an emergency use authorization for the lab giant's molecular test to permit self-collection of nasal samples. It comes days after FDA voiced concerns about at-home diagnostics to test for the virus.

By Greg Slabodkin • April 21, 2020

ResMed to get biggest bang out of HHS ventilator contracts, analysts predict

Medtronic and Hillrom may see limited gains from their smaller deals, but ​ResMed’s contract could add a 2.7% bump to growth in the fourth quarter, Needham analysts noted.

By Nick Paul Taylor • April 21, 2020

CMS, surgeons group offer paths forward to resume elective procedures

Johnson & Johnson, Abbott and Intuitive Surgical are among the device makers that reported the widespread deprioritization of surgeries during the pandemic dented sales at the end of the first quarter.  

By Susan Kelly • April 20, 2020

Massive coronavirus testing ramp-up needed for US to reopen: report

A Harvard-led study contends 5 million daily tests are needed by early June to “deliver a safe social reopening,” which will have to quadruple by late July to fully remobilize the economy. It's a long stretch from current testing capabilities.

By Greg Slabodkin • April 20, 2020

Philips to invest $109M as COVID-19 drives connected care order growth

CEO Frans van Houten said sourcing component parts from affected suppliers has been a challenge amid increasing demand for ventilators, patient monitors and certain diagnostic devices.

By Nick Paul Taylor • April 20, 2020

Patchy IT infrastructure hobbling COVID-19 response, commercial labs and public health officials warn

Labs have to comply with a variety of state and federal reporting laws, all while fielding separate requests for data from state health information exchanges, governors, Medicaid plans, government contractors, and others.

By Rebecca Pifer • April 17, 2020

FDA device review times could get iffy, agency chief says

"It is difficult to speculate on what the exact impact will be on incoming submissions moving forward," Commissioner Stephen Hahn said in an update on hitting MDUFA goals amid the constraints of the public health emergency.

By Maria Rachal • April 17, 2020

EU MDR delay clears Parliament, enters final stages

During a plenary focused on combating the coronavirus pandemic, the European Parliament on Friday voted overwhelmingly in favor of pushing back the regulatory overhaul. A few steps remain.

By Nick Paul Taylor • April 17, 2020

GE, Ford get $336M HHS contract for 50K lower-cost ventilators

The latest deal works out to about $6,720 per ventilator. GE's roughly $64 million contract for 2,410 ventilators detailed earlier this week works out to a little more than $26,000 per device. 

By Nick Paul Taylor • April 17, 2020