Diagnostics: Page 11
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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 -
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 -
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 -
Q&A
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 -
Recall of Roche partner’s COVID tests labeled as Class I
The at-home COVID tests, made by SD Biosensor and distributed by Roche, were recalled for bacterial contamination.
By Elise Reuter • Updated June 8, 2023 -
Illumina accused of ‘playing delay tactics’ to push back EU decision on divesting Grail: Financial Times
Delaying the decision to divest Grail could let Illumina sell the liquid biopsy business when the market is more favorable.
By Nick Paul Taylor • May 30, 2023 -
Abbott’s remote heart failure monitoring system reduces hospitalizations in clinical trial
The study is the third randomized, controlled trial globally to link CardioMEMS to a significant health benefit.
By Nick Paul Taylor • May 26, 2023 -
Illumina chair loses to Icahn pick as proxy battle ends
The decision to replace board Chair John Thompson could change the company’s course as it decides whether to divest liquid biopsy company Grail.
By Elise Reuter • Updated May 25, 2023 -
Slump in medtech VC activity continues as inflation keeps investors on the sidelines
Investors struck deals worth $1.8 billion over the first three months of the year, down from $3.0 billion across the start of 2022.
By Nick Paul Taylor • May 25, 2023 -
Acurable prepares to challenge ResMed for sleep apnea diagnosis market
The company’s device records the sounds of the patient’s respiratory and cardiac functions and monitors blood oxygen levels to assess suspected obstructive sleep apnea.
By Nick Paul Taylor • May 25, 2023 -
Illumina, Icahn prepare for proxy showdown
Can Carl Icahn bend Illumina to his will? Shareholders will vote Thursday on removing the company’s CEO and chairman from the board and replacing them with nominees from the activist investor.
By Elise Reuter • May 24, 2023 -
Abbott cuts 199 jobs amid dwindling demand for COVID tests
The staff reductions at Abbott’s Westbrook manufacturing plant come as the company forecasts decreasing demand for the tests in 2023.
By Elise Reuter • May 24, 2023 -
PulseAI algorithm beats Apple Watch software at detecting atrial arrhythmias
In a head-to-head comparison with Apple’s pre-installed software for interpreting ECG data, Pulse AI’s algorithm was better at detecting atrial arrhythmias.
By Nick Paul Taylor • May 23, 2023