Diagnostics: Page 30
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Sarah Silbiger via Getty Images
Neuromodulation and cancer devices feature in latest batch of FDA breakthrough nods
Neuroelectrics, Neuros Medical and Onward are among those that secured the regulatory privilege, which speeds the review process for unmet medical needs.
By Nick Paul Taylor • July 2, 2021 -
Sarah Silbiger via Getty Images
PMA apps could hit record in 2021, pressuring a pandemic-stressed FDA
Despite increased workloads from the coronavirus crisis, the agency is also on track to issue record numbers of safety warnings and letters to healthcare providers in 2021, according to a Wells Fargo analysis.
By Nick Paul Taylor • July 2, 2021 -
Abbott
COVID-19 antigen testing on par with PCR when used often: NIH-funded study
The two diagnostic methods were equally effective in detecting SARS-CoV-2 infection. The results could be good news for antigen test makers Abbott, Becton Dickinson and Quidel.
By Greg Slabodkin • July 1, 2021 -
Courtesy of Abbott
Abbott gets CE mark to sell COVID-19 antigen test directly to consumers in Europe
The company's rapid Panbio diagnostic received the marking in January for asymptomatic coronavirus screening. However, the test missed half of COVID-19 cases in people without symptoms, according to a recent Irish study.
By Greg Slabodkin • June 28, 2021 -
Permission granted by E.A. Crunden
Lawmakers reintroduce diagnostic regulation bill that split the industry
The VALID Act would create a risk-based regulatory framework for in vitro diagnostics and laboratory-developed tests. ACLA, whose members include Quest and LabCorp, is reviewing the bill but has objected to earlier drafts.
By Nick Paul Taylor • June 25, 2021 -
EU clarifies Eudamed rules for legacy and custom-made devices
The Medical Device Coordination Group has provided information on products placed on the market under frameworks other than MDR and IVDR, which the advisers said should be registered in the database.
By Nick Paul Taylor • June 25, 2021 -
Danielle Ternes/MedTech Dive
PerkinElmer, Qiagen latest medtechs to target rapidly growing CRISPR market
Qiagen launched new products to enable researchers to better analyze the gene editing impact of their work, while PerkinElmer bought viral vector gene delivery company SIRION Biotech to complement its CRISPR portfolio.
By Greg Slabodkin • June 23, 2021 -
Courtesy of Siemens Healthineers
UnitedHealthcare skimping on COVID-19 test pay: California doctors group
The California Medical Association says UnitedHealthcare still is not covering the cost of all COVID-19 diagnostic testing, despite state and federal guidelines that require the services to be provided at no cost to patients.
By Susan Kelly • June 21, 2021 -
UK extends OK of Innova COVID-19 test criticized by FDA in warning letter
While U.S. regulators told the public to put Innova tests in the trash, a review by the U.K. counterpart found no problems that warranted further actions.
By Nick Paul Taylor • June 18, 2021 -
Sarah Silbiger via Getty Images
LetsGetChecked receives EUA for use of at-home COVID-19 collection kit by minors
The virtual healthcare company, which last week announced $150 million in Series D financing, is competing with companies including LabCorp for the pediatric testing market.
By Nick Paul Taylor • June 16, 2021 -
Stefani Reynolds / Stringer via Getty Images
MedPAC says lower clinical lab fees don't impact access, prompting ACLA ire
The clinical laboratory group, whose members include Quest and LabCorp, contends that MedPAC's report to Congress contains "biased" commentary that ignores the value of lab tests and importance of timely patient access.
By Nick Paul Taylor • June 16, 2021 -
Courtesy of Abbott
Abbott's Panbio antigen test misses half of asymptomatic COVID-19 cases in Irish study
The finding led Ireland to recommend against using single, standalone antigen kits for the purposes of such screening.
By Nick Paul Taylor • June 15, 2021 -
Sarah Silbiger via Getty Images
FDA rejects Verily filing for wrist-worn Parkinson's clinical trial device
The sister company of Google developed the feature to collect data on the motor function of Parkinson's patients in between visits to trial sites. However, the agency questioned the wearable's ability to have a meaningful effect.
By Nick Paul Taylor • June 14, 2021 -
National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Image]. Retrieved from Flickr.
FDA blasts Innova for shipping unapproved COVID-19 test, using false or misleading labeling
The agency hit the California-based medtech with a flurry of actions on Thursday, firing off a warning letter alongside notice of a Class I recall and a press release telling the public to stop using the antigen test.
By Nick Paul Taylor • Updated June 11, 2021 -
Retrieved from C-SPAN on February 23, 2021
HHS warns providers, insurers COVID-19 testing must be free for patients
The American Clinical Laboratory Association, which includes Quest Diagnostics and LabCorp, has complained that guidance on the topic had only served to muddy what they saw as clear congressional mandates.
By Greg Slabodkin • June 10, 2021 -
EU provides plan to meet 'serious challenge' of readiness for IVDR
The document by the Medical Device Coordination Group is designed to ensure "limited resources" are focused on the activities that are critical to being ready by May 2022.
By Nick Paul Taylor • June 10, 2021 -
Justin Sullivan via Getty Images
Amazon offers COVID-19 test online to consumers with a website for viewing results
The tech giant's coronavirus diagnostic, which received FDA emergency authorization in March, was originally designed for use by company employees but is now available for $39.99 to the public.
By Nick Paul Taylor • Updated June 16, 2021 -
Courtesy of BD/PRNewswire
BD doubles down on COVID-19 testing outlook, despite Abbott warning about demand drop-off
CEO Tom Polen told investors the company stands by its guidance for the rest of the year of $1.8 billion to $1.9 billion in revenue for coronavirus diagnostics, regardless of "anything our competitors have announced."
By Greg Slabodkin • June 8, 2021 -
National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Micrograph]. Retrieved from Flickr.
OraSure gets EUAs to enter shrinking COVID-19 antigen test market
The technology is differentiated from other rapid antigen tests but is coming to market amid what Abbott characterized as a "sharp and rapid" drop in demand.
By Nick Paul Taylor • June 8, 2021 -
Sarah Silbiger via Getty Images
Cancer tech dominates FDA's latest batch of breakthrough devices
The agency's recent breakthrough designations feature a clutch of oncology devices and diagnostics from companies including Viome and Avenda Health.
By Nick Paul Taylor • June 7, 2021 -
Grail starts selling multi-cancer liquid biopsy Galleri in the US
The move comes as regulators scrutinize a $7.1 billion buyout bid by Illumina. Grail will face the challenge of getting insurers' support while competing with Guardant Health, Exact Sciences and Freenome.
By Nick Paul Taylor • June 7, 2021 -
Cognoa's machine learning software for autism diagnosis gets FDA nod
The software as a medical device, which uses an algorithm, reports a positive or negative diagnosis based on analyses of videos of the child and other information. The product got FDA's breakthrough designation in early 2019.
By Nick Paul Taylor • June 3, 2021 -
Abbott
Abbott's COVID-19 testing surprise suggests demand softening faster than sector forecast
The medtech on Tuesday cut its 2021 outlook blaming a sharp, rapid decline in demand for its coronavirus-related tests on vaccinations. The sudden hit to test volumes could be a harbinger for the diagnostics sector.
By Greg Slabodkin • June 2, 2021 -
Courtesy of Abbott
Abbott cuts 2021 outlook, blaming rapid decline in COVID-19 testing demand
CEO Robert Ford described a "sharp and rapid" drop-off in demand, a trend the company expects to continue. Shares slumped 7% on the news.
By Greg Slabodkin • June 1, 2021 -
ACLA appeals dismissal of PAMA lawsuit, pushes legislative fixes
The lab trade group for Quest, LabCorp and others argues the Protecting Access to Medicare Act is a case of "harmful regulatory overreach" that forces an "unsustainable reimbursement model" on its members.
By Nick Paul Taylor • June 1, 2021
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