Diagnostics: Page 48
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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 -
Courtesy of Centers for Disease Control and Prevention
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 -
Explore the Trendline➔
Permission granted by Boston Scientific
TrendlineNew medical devices are reshaping the medtech industry
From pulsed field ablation devices to glucose sensors and surgical robotics, new medical technologies are transforming patient care and how people manage their health.
By MedTech Dive staff -
Retrieved from Abbott, PRNewswire on March 19, 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 -
Jacob Bell/MedTech Dive
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 -
Courtesy of Qiagen
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 -
Permission granted by Roche
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 -
Retrieved from Flickr.
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 -
"State Public Health Laboratory in Exton Tests for COVID-19" by Governor Tom Wolf is licensed under CC BY 2.0
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 -
Master Sgt. Hecht, Matt. (2020). [Photograph]. Retrieved from Flickr.
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 -
Courtesy of Abbott
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 -
"State Public Health Laboratory in Exton Tests for COVID-19" by Governor Tom Wolf is licensed under CC BY 2.0
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
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