Diagnostics: Page 22
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MedTech Europe pushes for semiconductor prioritization as US moves to increase local supply
The trade group wants political action to stop patient harm from “a growing divergence” between semiconductor supply and demand.
By Nick Paul Taylor • July 27, 2022 -
Patrik Stollarz / Staff via Getty Images
Philips shares hit 10-year low as supply chain challenges weigh on revenue
Sleep apnea machine recall adds to woes as sales forecast is slashed for remainder of 2022.
By Elise Reuter • July 25, 2022 -
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 -
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Johns Hopkins sepsis alert tool reduced patient deaths, studies find
Three prospective studies of a machine learning tool developed by a Johns Hopkins spinout found it led to earlier antibiotic treatment and reduced patient mortality.
By Elise Reuter • July 22, 2022 -
Permission granted by Mayo Clinic
Q&AFriday Q&A: Matthew Binnicker, Mayo Clinic's director of clinical virology, talks COVID-19, monkeypox testing
With cases of both viruses rising across the U.S., clinical laboratories are bringing in staff to ramp up monkeypox testing, even as demand falls for clinical diagnostics of COVID-19.
By Elise Reuter • July 22, 2022 -
Courtesy of Roche
Roche CEO Schwan, who guided company as cancer drug powerhouse, to step down next year
The drugmaker’s current diagnostics chief Thomas Schinecker will take over as CEO in March, while Schwan will seek election as chair of Roche’s board.
By Jonathan Gardner • July 21, 2022 -
Dan Zukowski/MedTech Dive
Test makers urge House, Senate to include diagnostic reforms in user-fee bill
AdvaMedDx, Abbott and Roche are among companies asking lawmakers to address the “urgent public health issue.”
By Nick Paul Taylor • July 21, 2022 -
Courtesy of Quest Diagnostics
Quest Diagnostics raises 2022 revenue forecast amid continued demand for COVID testing
The company boosted its outlook for the diagnostics unit even as the division posted a 31% decline in revenue in the second quarter.
By Ricky Zipp • July 21, 2022 -
Courtesy of Abbott
Abbott's Q2 sales boosted by COVID-19 testing; outlook for diagnostics demand remains uncertain
The company’s $2.3 billion in COVID-19 testing sales beat J.P. Morgan and Stifel analysts’ estimates by about $1 billion, while CEO Robert Ford cautioned that forecasting demand remains challenging.
By Ricky Zipp • July 20, 2022 -
Jessica McGowan/Getty Images via Getty Images
Sonic Healthcare joins CDC's monkeypox testing push to further grow capacity
Providers can order the Sonic Healthcare test as they would any other service, opening another pathway to diagnose a virus that has now infected almost 2,000 people in the U.S.
By Nick Paul Taylor • July 19, 2022 -
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Diagnostic sector faces a 'challenging set-up' amid economic slowdown: analysts
Goldman Sachs warned there will be “limited visibility over the course of the year,” adding that companies may need to focus more on demonstrating their paths to profitability.
By Nick Paul Taylor • July 19, 2022 -
Illumina fails to block EU antitrust review of $8B Grail merger
By siding with the European Commission, the General Court has cleared the EU to resume a review that could lead to it blocking the deal and fining Illumina.
By Nick Paul Taylor • July 18, 2022 -
Permission granted by Columbia University
Q&AFriday Q&A: Ian Lipkin, Columbia epidemiologist, talks COVID-19 testing as U.S. sees another wave
Lipkin explained why he’s not a fan of antigen tests, and stressed the need to keep PCR testing a core part of the pandemic response.
By Elise Reuter • July 15, 2022 -
Mario Tama/Getty via Getty Images
Abbott, Intuitive, J&J to kick off quarterly earnings season next week as recession threat looms
Earnings results are poised to set expectations for the impact of a potential slowdown and shed light on trends with implications for companies including Boston Scientific, Medtronic and Stryker.
By Nick Paul Taylor • July 15, 2022 -
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Labcorp launches blood test for neurodegenerative disease biomarker
The test could detect Alzheimer’s before it manifests in routine imaging or clinical symptoms, helping physicians assess the effectiveness of treatments.
By Nick Paul Taylor • July 14, 2022 -
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EC publishes IVDR guidance in absence of completed Eudamed database
The commission recently announced a timeline for complete implementation of Eudamed, aiming for the second quarter of 2024.
By Ricky Zipp • July 13, 2022 -
Spencer Platt via Getty Images
Deep DiveWith COVID testing on the wane, small diagnostics companies shift focus
Startups that grew quickly from large contracts are looking nervously to a new future, as demand plummets for mass testing and shifts to homes.
By Elise Reuter • July 13, 2022 -
Pablo Blazquez Dominguez via Getty Images
Quest launches monkeypox PCR test as U.S. attempts to catch up with rising cases
The company estimates it will be able to process 30,000 tests per week by the end of July. As of July 12, there were 929 confirmed cases in the U.S., the CDC reported.
By Ricky Zipp • July 13, 2022 -
Permission granted by CathWorks
Medtronic lands option to buy artery disease player CathWorks for up to $585M
CathWorks has the right to compel Medtronic to complete the acquisition if it chooses not to exercise its option.
By Nick Paul Taylor • July 13, 2022 -
Carl Court via Getty Images
Hologic, Thermo Fisher roll out respiratory panels for Europe ahead of cold and flu season
Australia’s experience suggests Europe and other parts of the northern hemisphere may face high levels of respiratory disease this winter.
By Nick Paul Taylor • July 12, 2022 -
Carl Court via Getty Images
European Commission targets spring of 2024 for fully functional Eudamed database
The Commission is planning a two-phase transition to mandatory use of the database after it goes live.
By Nick Paul Taylor • July 11, 2022 -
Justin Sullivan via Getty Images
Labcorp starts offering monkeypox testing using the CDC's PCR test
Labcorp claims it will become the first national laboratory to offer the test by beating its chief rival to market.
By Nick Paul Taylor • July 8, 2022 -
Carl Court via Getty Images
High-risk IVD tests rules finalized by European Commission despite industry calls for change
MedTech Europe pushed back against some of the requirements, but the Commission has retained disputed parts of the document.
By Nick Paul Taylor • July 8, 2022 -
Phil Walter via Getty Images
SD Biosensor agrees to buy Meridian Bioscience for $1.53B in bid to enter U.S. IVD market
The Cincinnati-based diagnostics company says being acquired will help it enter new markets as part of SD Biosensor, as the COVID-detection business wanes.
By Elise Reuter • July 7, 2022 -
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Semiconductor shortage leaves medtech industry 'more pessimistic' as customers leave, says Deloitte
Hospitals and health systems are looking into alternative products as a result of the disruption, according to a report from Deloitte and AdvaMed.
By Nick Paul Taylor • July 7, 2022 -
Sarah Silbiger via Getty Images
American Contract Systems' COVID-19 test recall gets Class I label from FDA
Off-site assembly by workers who may not have been properly trained prompted the company to recall COVID-19 tests amid concerns they may yield false results.
By Nick Paul Taylor • Updated July 6, 2022
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