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

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➔

Medical 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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Proposed 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

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

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

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

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

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

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

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