Diagnostics: Page 12
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Illumina faces SEC probe over Grail acquisition
The securities regulator has asked for documents tied to the 2021 deal in addition to the conduct and compensation of members of Illumina and Grail management.
By Susan Kelly • Aug. 14, 2023 -
Courtesy of Cue Health Press Kit
Cue Health wins $28M BARDA contract to develop rapid respiratory infection test
The company plans to launch the respiratory panel for the 2024-25 virus season and aims to break even in 2025.
By Nick Paul Taylor • Aug. 14, 2023 -
Explore the Trendline➔
Sara Silbiger via Getty Images
TrendlineTop 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 -
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Median lag between FDA authorization and Medicare coverage hits 6 years: study
Fewer than 30% of novel medical devices obtain some Medicare coverage in the three years after regulatory authorization, researchers found.
By Nick Paul Taylor • Aug. 11, 2023 -
Courtesy of Illumina
Illumina shakes up executive team, lowers 2023 outlook
The gene sequencing industry leader, which is operating under an interim CEO, named a new chief technology officer and announced the departure of its chief medical officer.
By Susan Kelly • Aug. 10, 2023 -
Courtesy of GuardantHealth
Guardant, Illumina agree to end litigation, extend commercial partnership
The two sides will now renew a long-term collaboration to advance cancer research, Guardant said.
By Susan Kelly • Aug. 8, 2023 -
Courtesy of Illumina
Pressure mounts for Illumina to divest Grail amid record fine, executive changes
Illumina is facing a 432 million euro fine from European regulators and is looking for a new CEO.
By Elise Reuter • Aug. 8, 2023 -
Courtesy of Abbott Laboratories
Abbott lands FDA clearance of Alinity complete blood count system
The company claims the device uses less floor space and has one of the highest throughputs as it competes with diagnostic systems made by Beckman Coulter and Siemens Healthineers.
By Nick Paul Taylor • Aug. 8, 2023 -
Thomas Andreas via Getty Images
AI reduces radiologist workload in mammography clinical trial but expert urges caution
The trial linked the AI-supported screen-reading procedure, ScreenPoint Medical’s Transpara, to a 44% reduction in radiologist workload.
By Nick Paul Taylor • Aug. 2, 2023 -
Retrieved from Siemsens Website on July 01, 2022
Varian logistics slow growth at Siemens Healthineers in Q3
Healthineers has worked through some logistics problems but now faces a race to install Varian equipment at customer sites.
By Nick Paul Taylor • Aug. 2, 2023 -
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 -
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 -
magicmine via 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 -
Stock via 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
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