Diagnostics: Page 13
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Courtesy of Quest Diagnostics
Quest launches consumer test to assess Alzheimer’s risk
As new drugs intended to slow cognitive decline reach the market, test makers see an opportunity for earlier detection of Alzheimer’s disease.
By Elise Reuter • July 31, 2023 -
National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Micrograph]. Retrieved from Flickr.
Demand for 4-in-1 test helps Danaher’s COVID sales beat internal forecast
Danaher said it is continuing to take market share as many customers look to consolidate their point-of-care PCR testing platforms.
By Nick Paul Taylor • July 26, 2023 -
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 -
Sarah Silbiger via Getty Images
FDA improves 510(k) turnaround times, but PMA waits hit record high: analysis
The time it took for the FDA to reach 510(k) decisions decreased by 24 days, but the agency is still working through a pandemic-driven backlog of premarket approval applications.
By Nick Paul Taylor • July 24, 2023 -
Courtesy of Abbott
Abbott Q2 net profit falls as weaker COVID test sales drag on revenue
Stronger medical device sales and a recovery in the infant formula business partly offset the impact of reduced COVID-19 testing.
By Susan Kelly • July 20, 2023 -
Getty Images
QuidelOrtho test could miss heart attacks, drawing Class I recall
The company advised clinicians to immediately discontinue using the test and switch to another method if possible.
By Elise Reuter • July 17, 2023 -
Sean Gallup / Staff via Getty Images
Illumina’s ‘inevitable’ split from Grail likely by mid-2024, analysts say
Canaccord Genuity analysts, commenting on a Financial Times article predicting a record EU fine against the DNA sequencer for closing its Grail acquisition, said it looks “almost certain” regulators will force a divestiture.
By Susan Kelly • July 6, 2023 -
iStock via Getty Images
Roche test for accelerating Alzheimer’s diagnosis granted FDA clearance
As treatments for early Alzheimer’s disease come to market, demand for techniques to accelerate diagnosis could increase.
By Nick Paul Taylor • June 30, 2023 -
Courtesy of Illumina
Illumina plans layoffs, closure of San Diego facility in push to save $100M a year
As well as exiting the San Diego site, Illumina is “evaluating its options” for another California campus in Foster City.
By Nick Paul Taylor • June 27, 2023 -
Permission granted by FujiFilm USA/Francisco Gonzalez
OpinionProposed breast cancer screening recommendations don’t go far enough
A proposal by a government-sponsored task force calling for a 24-month spacing between mammograms fails to address the latest research and may further exacerbate disparities and mortality outcomes, argues Henry Izawa, head of FujiFilm Healthcare Americas.
By Henry Izawa • June 21, 2023 -
Courtesy of Exact Sciences/Business Wire
Exact Sciences’ next-gen colorectal cancer test hits primary goals in pivotal study
The analysis suggests the new stool-based test provides more true positives and fewer false positives than its predecessor.
By Nick Paul Taylor • June 21, 2023 -
Courtesy of Siemens Healthineers
Siemens Healthineers laying off 67 people as $327M diagnostic cost-cutting push begins
The action comes months after the company’s CEO said “the dramatically changed macroeconomic environment” for diagnostics “demands immediate and comprehensive measures.”
By Nick Paul Taylor • June 20, 2023 -
Courtesy of Abbott Laboratories
Abbott names Philip Boudreau as CFO
Current CFO Robert Funck will become executive vice president of finance, with the company making a series of internal promotions to fill the roles of CFO and controller.
By Elise Reuter • June 13, 2023 -
Kevin Dietsch via Getty Images
As Illumina’s deSouza departs, will Grail go next?
The CEO’s resignation could signal a change of direction, as anti-trust regulators order Illumina to divest the liquid biopsy unit.
By Susan Kelly • June 12, 2023 -
Kevin Dietsch via Getty Images
Illumina CEO Francis deSouza resigns weeks after surviving Icahn board battle
DeSouza has left unrepentant about his decision to close the Grail deal, telling colleagues his belief in the merger “remains unshakeable.”
By Nick Paul Taylor • June 12, 2023 -
Getty Images
Precision Neuroscience’s brain implant maps electrical activity in a first-in-human trial
Created by a founder of Elon Musk’s Neuralink, Precision has developed a device with some 1,000 electrodes in a one square centimeter flexible film. The trial could open the way to a computer-brain interface.
By Nick Paul Taylor • June 8, 2023 -
Courtesy of Cue Health Press Kit
Cue Health wins first non-emergency authorization for COVID test, days after Goldman downgrade
The FDA’s marketing authorization for Cue’s COVID-19 molecular test could boost consumer access, but the company faces strong competition from more established diagnostic firms.
By Peter Green • June 7, 2023 -
Permission granted by VideaHealth
Q&AHow they built it: Florian Hillen wants to look at your teeth with his AI
Hillen is building a business on the premise that using artificial intelligence to examine dental X-rays can nearly double diagnostic accuracy, and help detect other diseases.
By Peter Green • June 7, 2023 -
Courtesy of Penn State University/Huanyu “Larry” Cheng
Low-cost, disposable ‘pencil-on-paper’ sensor opens population health opportunities
Designed by the research team that developed the smart diaper, the paper patch could be used to detect cardiopulmonary disease and treat inflammation, or monitor disease outbreaks.
By Nick Paul Taylor • June 7, 2023 -
Illumina appeals FTC’s order to divest Grail with plea for cancer screening test
The DNA-sequencing company that has been fighting regulators over orders to reverse its 2021 acquisition of Grail is accusing the U.S. government of overreach and collusion with European regulators.
By Susan Kelly • June 6, 2023 -
Courtesy of Cue Health Press Kit
Cue Health’s inability to find post-COVID markets for testing prompts Goldman downgrade
The analysts warned switching to non-COVID-19 tests will mean entering a competitive market “where larger companies with financial resources have an established installed base.”
By Nick Paul Taylor • June 5, 2023 -
Courtesy of Grail
Grail blames vendor glitch for patient notifications of incorrect cancer diagnosis
The erroneous letters from telemedicine provider PWNHealth come as Grail’s parent company, Illumina, is facing pressure from regulators and shareholders to divest the liquid biopsy maker.
By Susan Kelly • June 5, 2023 -
Getty Images
Illumina trains AI on primate data to estimate risk of rare variants in humans
The results suggest AI can help improve genetic risk prediction for healthy humans, which could boost demand for Illumina’s gene sequencing devices.
By Nick Paul Taylor • June 2, 2023 -
Courtesy of Illumina
Illumina adds 2 medtech execs to its board, weakening Icahn’s influence
Hologic CEO Stephen MacMillan and Edwards Lifesciences CFO Scott Ullem join just a week after chair John Thompson was ousted in a proxy battle with Icahn.
By Susan Kelly • June 2, 2023 -
Retrieved from Medtronic on June 01, 2023
Medtronic’s Brewer jumps to Baxter to lead patient support systems
Julie Brewer spent nearly 17 years at Medtronic, most recently in the role of president of cardiovascular diagnostics and services.
By Susan Kelly • Updated June 1, 2023 -
Getty Images
Patient advocacy groups urge FDA to regulate lab-developed tests if VALID Act doesn’t pass
Legislation has been proposed in Congress to bring diagnostic tests under a single regulatory framework, but if it doesn’t pass, the FDA has authority to regulate lab-developed tests, the groups said.
By Elise Reuter • May 31, 2023
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