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

How 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

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

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

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

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

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

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

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

MedTech Europe sets out position on cybersecurity, making case for reliance on MDR

As the number of connected medical devices grows, the industry group argues that Europe’s new medtech regulations should remain “the primary avenue” for medical device cybersecurity.

By Nick Paul Taylor • Updated June 12, 2023