Diagnostics: Page 30
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Abbott latest to report pandemic recovery in Q2 as procedures return, COVID-19 tests drag diagnostics
While growth was positive across the four major businesses, coronavirus test sales came in at $1.3 billion, far below the $2.2 billion reported in the previous quarter, though ahead of lowered expectations.
By Greg Slabodkin • July 22, 2021 -
FDA seeks funds, powers to fix ‘great weaknesses’ in medical device supply chain
Acting FDA Commissioner Janet Woodcock wants Congress to give the agency “expanded authority to obtain supply disruption notifications for critical devices any time there is the potential for a shortage.”
By Nick Paul Taylor • July 22, 2021 -
Explore the Trendline➔
Sara Silbiger via Getty ImagesTrendlineTop 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 -
PacBio inks $800M Omniome buyout to expand into short-read sequencing
The acquisition will give Pacific Biosciences access to early-stage cancer screening and recurrence monitoring markets. The bid comes 18 months after Illumina scrapped plans to acquire PacBio amid regulatory pushback.
By Nick Paul Taylor • July 21, 2021 -
Abbott, Intuitive and J&J kick off medtech earnings as COVID-19 bellwethers
Intuitive and J&J are set to report results this week that will shed light on the recovery of elective procedures, while Abbott will provide insights into the drop in coronavirus test demand.
By Nick Paul Taylor • July 19, 2021 -
National Institute of Allergy and Infectious Diseases. (2020). “Novel Coronavirus SARS-CoV-2” [Image]. Retrieved from Flickr.
FDA grants Curative request to revoke COVID-19 test EUA, company pivots to Abbott kits after false result risk
The agency, which announced the revocation on Thursday, originally granted an emergency use authorization to Curative’s test in April 2020. By January, FDA had concerns about false results potentially linked to sample collection.
By Nick Paul Taylor • July 16, 2021 -
Qiagen joins Abbott, Quidel cutting 2021 outlook as COVID-19 test demand wanes
CEO Thierry Bernard blamed a faster-than-expected testing drop and uptick of vaccinations. Jefferies said the downgraded targets are disappointing, particularly given management’s forecast reiteration last month.
By Greg Slabodkin • July 13, 2021 -
MDUFA talks expose ‘fundamentally different’ views of FDA and device companies
At the latest meeting over user fees, industry remained opposed to the agency’s pitch for a Total Product Life Cycle Advisory Program, which it contends would extend the scope beyond FDA’s purview.
By Nick Paul Taylor • July 12, 2021 -
Abbott lays off 400 workers amid drop in demand for COVID-19 tests
The company cut its 2021 outlook in June, blaming a sharp, rapid decline in demand for its coronavirus-related diagnostics on global vaccination efforts. The downward trend is anticipated to continue, an Abbott spokesperson said.
By Greg Slabodkin • July 9, 2021 -
Quidel COVID-19 PCR recall dubbed Class I by FDA due to false negative risk
The diagnostic company said it worked with FDA to confirm “a rare potential” for false test results and that the notice alerts lab customers of label changes made two months ago with no products removed from shelves.
By Nick Paul Taylor • Updated July 9, 2021 -
As EU-wide health technology oversight law nears passage, industry is not pleased
If passed, the legislation mandates European Union clinical assessments of certain medical devices to inform national-level pricing and reimbursement decisions.
By Nick Paul Taylor • July 6, 2021 -
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 -
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 -
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 -
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 -
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 -
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 -
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 -
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 -
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 -
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 -
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