Diagnostics: Page 46
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FDA Breakthrough Devices Program nears 300 designations
The agency has tapped 50 devices so far this year, with recent nods to Orteq, Thermedical, ArcherDX, Helius, PhotoPharmics and Terumo.
By Susan Kelly • May 27, 2020 -
CDC seeks to limit false positives with COVID-19 antibody testing, as immunity question lingers
The interim guidelines promote using high-specificity assays and conducting confirmatory tests when appropriate. However, the agency won't yet use serologic test results to sway public health recommendations.
By Nick Paul Taylor • May 27, 2020 -
Explore the Trendline➔
Sara Silbiger via Getty Images
TrendlineTop 5 stories from MedTech Dive
From haphazard layoffs at the Food and Drug Administration to the industry’s current IPO environment and tracking FDA-authorized AI devices, here is a collection of top stories from MedTech Dive.
By MedTech Dive staff -
Abbott, Roche ink deals with UK for 10M coronavirus antibody tests
The notice from the government, which bought $20 million in unreliable antibody tests early in the crisis, came as FDA removed 28 products from a list of the tests that can be used without emergency use authorizations.
By Nick Paul Taylor • May 22, 2020 -
Hospitals push FEMA to form broad supply pact with medtech
The agency on Thursday is set to discuss a proposed five-year voluntary agreement with industry to better distribute medical products, which health systems hope will go beyond personal protective equipment.
By Nick Paul Taylor • Updated May 26, 2020 -
Labs welcome CMS rate for coronavirus antibody testing
Analysts at William Blair said the roughly $42 rate for common serological tests is higher than expected, which may bode well for antigen testing reimbursement.
By Nick Paul Taylor • May 20, 2020 -
Coronavirus pushes Mayo Clinic's operating income into free fall
Operating income plunged 88% by the end of the first quarter due to the pandemic and the near closure of the health system's outpatient business. Still, Mayo has become a leader in COVID-19 testing.
By Samantha Liss • May 19, 2020 -
Philips lung ultrasound, Beckman sepsis diagnostic receive BARDA coronavirus backing
The separate projects aim to incorporate machine learning algorithms to enhance technologies meant to support COVID-19 patients.
By Susan Kelly • May 19, 2020 -
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 -
Courtesy of Abbott
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 -
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 -
Rebecca Pifer/MedTech Dive
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 -
Courtesy of Abbott, PRNewswire
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 -
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 -
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 -
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 -
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
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