FDA OKs 1st at-home collection kit for use with multiple labs, coronavirus tests

The emergency use authorization to Everlywell follows earlier nods to LabCorp and Rutgers Clinical Genomics Laboratory for at-home specimen collection for analysis solely at their own labs.

By Nick Paul Taylor • May 18, 2020

Abbott on defense as FDA flags false negative reports with point-of-care coronavirus test

An independent study circulated this week showed the rapid ID Now COVID-19 test could miss 48% of positive cases under some conditions. Abbott said late Thursday a backup test should be performed in certain cases.

By Nick Paul Taylor • May 15, 2020

Explore the Trendline➔

Medical device industry continues to turn to AI

While the industry continues to embrace artificial intelligence, there are still questions about how the new technologies need to be regulated and if they are effective.

By MedTech Dive staff

House Dems carve out $75B for coronavirus testing, contact tracing in bid for new relief package

The $3 trillion bill passed the House by a vote of 208-199 on Friday. It's Democrats' opening gambit for the next wave of congressional action, but Republicans say they're not in a hurry to approve new funding.

By Susan Kelly • Updated May 18, 2020

Eko algorithm gets FDA nod for cardiac screening of COVID-19 patients

Developed with the Mayo Clinic, Eko's algorithm gained breakthrough device status in December and review was further accelerated given its potential to identify patients at higher risk of poor outcomes with the coronavirus.

By Nick Paul Taylor • May 13, 2020

As Trump pushes states to reopen, Fauci warns against lifting COVID-19 restrictions too soon

The U.S. doesn't have the necessary testing and surveillance infrastructure in place to prep for a fall resurgence of the coronavirus, a second wave that's "entirely conceivable and possible," Fauci told a Senate panel.

By Rebecca Pifer • May 12, 2020

LabCorp at-home collection test kit for coronavirus goes mainstream, as states get $11B for testing efforts

The tests, originally only offered to frontline workers, are now available even to individuals without symptoms who may have been exposed to the virus. Still, clinical labs say more support is needed to further ramp up capacity.

By Greg Slabodkin • May 12, 2020

Latest Abbott coronavirus antibody test receives FDA emergency use OK

The EUA is the company's second for a test detecting the IgG antibody, using a different machine than the first. Across both, it plans to ship almost 30 million units worldwide in May and double that amount in June. 

By Greg Slabodkin • May 11, 2020

1st antigen test to detect coronavirus gets FDA nod

The agency, which gave the green light on Saturday to Quidel, expects the tests to be cheaper to make than PCR tests.

By Nick Paul Taylor • May 11, 2020

Roundup: Q1 medtech reports give glimpse into coronavirus-era gains and losses

Much of the sector may be considered recession-proof — but it's not social distancing-proof. The last weeks of March previewed the dramatic trajectory of drops in routine testing and a mounting backlog of elective procedures.

By Maria Rachal • May 7, 2020

10 stories on the state of COVID-19 testing in the US

Despite medtechs' efforts to rapidly scale production of diagnostic and antibody tests, and commercial labs' work to make them more widely available, the U.S. still lacks adequate testing capacity, even as localities mull easing lockdowns. 

May 7, 2020

BD says surgery revenues fell as much as 70% in April

As it faces pandemic headwinds, BD is also continuing to deal with problems with its Alaris infusion pump system and modules and expects to record a $200 million charge related to remediation efforts.

By Greg Slabodkin • May 7, 2020

FDA details COVID-19 era reporting rules to stymie medical device shortages

Under new powers granted by the CARES Act for the duration of the health crisis, the guidance to industry lays out when and how to notify the agency about changes that could affect product availability.

By Nick Paul Taylor • May 7, 2020

Qiagen aims for 50-fold jump in coronavirus test reagent output

The company, in the midst of being acquired by Thermo Fisher, reached capacity in April to support 7 million real-time PCR tests to detect the virus, with a target of 20 million per month by year’s end.  

By Nick Paul Taylor • May 7, 2020

Fitbit launches its 1st large-scale, virtual AFib study

The atrial fibrillation detection effort follows work by wearables rival Apple targeting the stroke risk factor that affects 33.5 million people globally.

By Greg Slabodkin • May 6, 2020

Guardant offers 'encouraging' colorectal cancer screening update, as analysts await further data

The liquid biopsy developer is still amassing evidence as it aims to sell a minimally invasive screening tool rivaling stool-based test Cologuard.

By Susan Kelly • May 6, 2020

FDA beefs up coronavirus antibody test regs critics called 'recipe for disaster'

The Association of Public Health Laboratories praised the move. "This revised policy makes a lot of sense and should have been in place over the last six weeks," the group's CEO Scott Becker said.

By Greg Slabodkin • May 4, 2020

Roche gets emergency OK for coronavirus antibody test

The diagnostics giant cited internal research that its product may be less likely to deliver false positives than some earlier-to-market serology tests, a concern regulators seek to address with a policy change Monday.

By Nick Paul Taylor • Updated May 4, 2020

CMS eases rules on COVID-19 diagnostics, antibody testing

A written practitioner’s order is no longer needed to obtain Medicare payment for diagnostic testing. The agency will also cover serology testing, including certain FDA-authorized tests for which patients collect samples at home.

By Hailey Mensik • May 1, 2020

Hologic to launch 2nd coronavirus test amid broader sales slide

The molecular diagnostics business posted its best growth rate in eight years, but the breast health and surgical segments slowed as a result of postponed elective surgeries.

By Susan Kelly • April 30, 2020

AdvaMed pushes US to lift tariffs on Chinese imports of COVID-19 devices

The trade group wants indefinite exemptions for imaging components and devices used in ventilators, among other items. It also floated a compromise: re-imposing them one year after the pandemic passes.

By Nick Paul Taylor • April 30, 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

Thrive, chasing Grail with a cancer blood test, finds tumors in seemingly healthy women

A first-of-its-kind trial of 10,000 women supported the test's potential to catch some cancers early. But whether it can truly help people is not entirely clear.

By Ben Fidler • April 28, 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