Diagnostics: Page 17
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Courtesy of Quest Diagnostics
Quest Diagnostics raises 2022 revenue forecast even as Q3 sales slump; shares climb
The diagnostics firm says a shift in emphasis away from COVID-19 testing is paying off.
By Peter Green • Oct. 20, 2022 -
Brendan Hoffman via Getty Images
Testing overhaul faces a ‘narrow pathway’ to pass before year end, industry groups say
Despite bipartisan support, a bill to allow the FDA to regulate lab-developed tests still faces hurdles to inclusion in an omnibus spending package.
By Elise Reuter • Oct. 20, 2022 -
Explore the Trendline➔
Sitthiphong via Getty Images
TrendlineMedical 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 -
Courtesy of Abbott
Abbott Q3 device sales slowed by supply chain pressures; COVID-19 tests exceed expectations
The company raised its earnings forecast for 2022 on the back of an expected $7.8 billion in annual sales related to COVID-19 testing.
By Elise Reuter • Oct. 19, 2022 -
Courtesy of Magnolia
BD forms co-promotion pact with Magnolia to reduce blood culture contamination
Magnolia’s blood collection device diverts the first 1.5 to 2 milliliters of blood samples that may be contaminated with flecks of skin, paving the way for more accurate diagnosis of sepsis.
By Nick Paul Taylor • Oct. 19, 2022 -
Sarah Silbiger via Getty Images
FDA seeks feedback on plans to draft and finalize medical device guidance in 2023
The agency’s review includes guidance on transitioning away from emergency use authorizations, while abandoning plans for guidance on software as a medical device.
By Nick Paul Taylor • Oct. 19, 2022 -
Joe Raedle / Staff via Getty Images
Avellino, Cepheid, GeneMatrix update COVID-19 test EUAs amid shift in FDA’s approach
COVID-19 test manufacturers have amended their fact sheets to state that diagnostics cleared or approved by the agency should be used instead of their emergency-authorized kits.
By Nick Paul Taylor • Oct. 17, 2022 -
Retrieved from Abbott/PRNewswire on June 15, 2020
Abbott, J&J and Intuitive to lead off medtech earnings season; procedures, supply chain in spotlight
Results from the three companies are expected to shed light on how the economic slowdown is affecting procedure trends in the industry.
By Nick Paul Taylor • Oct. 17, 2022 -
Permission granted by Becton Dickinson
Q&AFriday Q&A: BD’s Broache talks women’s health, at-home testing
Test adoption has increased as more customers have installed BD’s testing machines and the company hopes to offer more at-home assays in the U.S.
By Elise Reuter • Oct. 14, 2022 -
Vladimir Vladimirov/Getty Images via Getty Images
GE shores up contrast supply through deal with Chilean miner
A multiyear agreement with a Chilean mining company and the addition of a manufacturing line in Ireland will help GE insure against supply-chain disruptions.
By Elise Reuter • Oct. 13, 2022 -
GE advances healthcare spinoff plan, providing close look at workings of the unit
Localization requirements, third-party servicers, and more sophisticated data security threats are cited as risks to the healthcare unit.
By Nick Paul Taylor • Oct. 13, 2022 -
Retrieved from Jiangsu Well Biotech Co. on October 12, 2022
Jiangsu Well Biotech distributed unapproved COVID-19 tests, FDA says
The company is the latest firm to recall rapid antigen tests that had never received an emergency use authorization or clearance from the regulator.
By Elise Reuter • Oct. 12, 2022 -
Courtesy of Qiagen
Bio-Rad, Qiagen are in talks over $10B merger, WSJ reports
While the two companies have been in talks for some time, the deal may fall through, the report said, citing people familiar with the matter.
By Ricky Zipp • Updated Oct. 11, 2022 -
Courtesy of Abbot Molecular
Abbott lands FDA emergency authorization for first commercial monkeypox test
Abbott’s testing process is fully automated to increase throughput to help control the spread of monkeypox.
By Nick Paul Taylor • Oct. 10, 2022 -
Courtesy of Paige
Q&AFriday Q&A: Paige CEO Andy Moye on how digital pathology is changing the diagnostic game
Commercial laboratories and academic medical centers are starting to adopt digital tools to help pathologists detect cancer, opening a large market for AI-powered diagnostic tools.
By Elise Reuter • Updated Oct. 8, 2022 -
Courtesy of Summa Health
Quest agrees to buy Ohio-based health system’s lab-testing business
It’s the latest deal in a string of acquisitions by commercial laboratory companies as hospitals seek to cut costs and improve testing capacity.
By Elise Reuter • Oct. 6, 2022 -
iStock via Getty Images
Roche wins FDA approval for companion diagnostic to support breast cancer therapy
The approval positions Roche to support the rollout of AstraZeneca and Daiichi Sankyo’s Enhertu in HER2-low breast cancer.
By Nick Paul Taylor • Oct. 5, 2022 -
Stock via Getty Images
Genentech, Winterlight track changes in Alzheimer’s using automated speech-based system
The researchers called the system a “promising prototype,” while cautioning that further validation is needed.
By Nick Paul Taylor • Oct. 5, 2022 -
Permission granted by Roche
Roche Diagnostics taps new CEO
Matt Sause, the head of Roche Diagnostics’ North America region, is being promoted to lead the business.
By Elise Reuter • Oct. 4, 2022 -
Courtesy of Grail
Illumina looks to resolve Grail acquisition ‘sooner rather than later’: analysts
With a divestiture order from the European Commission looming, Illumina is looking at strategic options for the maker of blood tests used to detect cancer.
By Elise Reuter • Oct. 4, 2022 -
Stock via Getty Images
Medical machine-learning studies lack high-quality clinical trials, review shows
The findings “highlight areas of concern regarding the quality of medical machine learning RCTs and suggest opportunities to improve reporting.”
By Nick Paul Taylor • Oct. 4, 2022 -
Courtesy of Illumina
Illumina ushers in $200 genome with the launch of new sequencers
The company’s machines are part of a long line of products that have enabled Illumina to dominate the market for short-read sequencing.
By Nick Paul Taylor • Oct. 3, 2022 -
BillionPhotos.com
Digital pathology gains momentum among US providers, vendors: report
Already popular in Europe, digital pathology technologies are primed for growth in the U.S., according to a report from KLAS research.
By Hailey Mensik • Sept. 30, 2022 -
Drew Angerer via Getty Images
FDA switches COVID-19 tests to De Novo, 510(k) pathways, limiting EUAs
The FDA will still review EUA requests from “experienced developers” of tests that meet certain criteria.
By Nick Paul Taylor • Sept. 28, 2022 -
Permission granted by Becton Dickinson
BD launches research-use monkeypox test, plans EUA filing for clinical use
The rollout of the assay could benefit from the BD MAX machines that laboratories installed to test for SARS-CoV-2, according to the company.
By Nick Paul Taylor • Sept. 27, 2022 -
VCG / Stringer via Getty Images
Hospital procedures have remained steady since H2 in boost for medtechs, survey finds
Evercore ISI analysts said the findings bode well for device companies, even as hospitals expect capital spending to drop next year.
By Elise Reuter • Sept. 26, 2022
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