Diagnostics
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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 -
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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 -
Explore the Trendline➔
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TrendlineMedical device industry continues to turn to digital health, AI
While the industry continues to embrace digital health and artificial intelligence, there are still questions about how the new technologies and services need to be regulated and if they are effective.
By MedTech Dive staff -
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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 -
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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 -
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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 -
Sarah Silbiger via Getty Images
Puerto Rico-based lab ceases COVID-19 test; FDA revokes EUA
The FDA disclosed the action alongside updates to the instructions for use for Thermo Fisher Scientific’s TaqPath COVID-19 test.
By Nick Paul Taylor • Sept. 26, 2022 -
Kirill Smyslov via Getty Images
Forget oximeters, smartphone cameras detect 79% of cases of low blood oxygen in small study
If the results are validated by wider studies, physicians will have a new tool to increase the number of people who can be monitored for chronic and acute respiratory conditions.
By Nick Paul Taylor • Sept. 23, 2022 -
Cameron Spencer via Getty Images
Watchdog faults FDA for rushing COVID tests to market by easing emergency use rules
HHS’ Office of Inspector General found that by loosening emergency use authorization requirements to bring COVID-19 tests to market faster, the agency allowed inaccurate tests to be distributed.
By Elise Reuter • Sept. 21, 2022 -
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Racial bias in pulse oximeters to be subject of FDA panel
The design of the ubiquitous fingertip monitors has inadvertently caused false blood oxygen readings in darker-skinned patients, a problem the FDA hopes to fix.
By Peter Green • Sept. 16, 2022 -
Karen Ducey via Getty Images
FDA eases authorization policy for monkeypox tests as lab group points to ‘lessons learned’ from Covid-19
Laboratory group says new agency guidance that offers templates and more time to submit data should help test developers.
By Elise Reuter • Sept. 15, 2022 -
Spencer Platt via Getty Images
Medtech firms increasingly positive about future as staffing, inflation pressures ease, say RBC analysts
Hospital staffing and supply chain issues are expected to improve, according to comments from Boston Scientific, J&J, Medtronic, and others.
By Nick Paul Taylor • Sept. 15, 2022 -
Courtesy of Grail
Amid merger turmoil, Illumina’s Grail unit reports downturn in accuracy of blood-based cancer test
New data on Grail’s cancer screening test could weaken the company’s competitive standing against rivals Guardant Health, Exact Sciences and Freenome.
By Nick Paul Taylor • Sept. 12, 2022 -
Permission granted by Becton Dickinson
Q&AFriday Q&A: BD Life Sciences President Dave Hickey shares plans for expanded testing ‘menu’
Demand for COVID-19 tests may be slowing, but more laboratories have installed testing systems during the pandemic, the executive says.
By Elise Reuter • Sept. 8, 2022 -
Pablo Blazquez Dominguez via Getty Images
FDA issues first EUA for monkeypox test
Quest Diagnostics' PCR test for monkeypox received emergency use authorization after the FDA issued guidance on how it will evaluate the tests.
By Elise Reuter • Sept. 8, 2022 -
Karen Ducey via Getty Images
HHS will allow EUAs for monkeypox tests to increase access in the US
The move follows the declaration of a public health emergency for the monkeypox outbreak on Aug. 4.
By Ricky Zipp • Sept. 7, 2022 -
Courtesy of Illumina
Illumina’s hold on Grail depends now on separate appeals in U.S., Europe
Even as it plans to appeal a European Commission decision and the FTC plans to appeal a U.S. ruling, Illumina say it’s preparing for ‘strategic alternatives’ to its acquisition of early cancer detection firm Grail.
By Elise Reuter • Updated Sept. 7, 2022 -
Screenshot from WKTU TV. (2019). [Photo]. Retrieved from WKTU TV.
Federal jury convicts medtech executive in $77M blood testing kickback case
Arrayit President Mark Schena’s conviction on nine federal charges carries a maximum sentence of more than 100 years in prison.
By Nick Paul Taylor • Sept. 6, 2022 -
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Machine learning algorithm predicts unfavorable labor outcomes for mothers in retrospective study
The researchers plan to validate the model using Mayo Clinic patients before deploying it prospectively in maternity wards.
By Nick Paul Taylor • Sept. 6, 2022 -
Phil Walter via Getty Images
Another COVID-19 test supplier ordered by FDA to take its products off the market
USA Medical has been warned by FDA that its rapid antigen tests had not been cleared or authorized by the agency.
By Elise Reuter • Sept. 1, 2022
