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

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

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

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

Thermo Fisher gets FDA clearance for first blood test of severe preeclampsia risk

A study found the test is a better predictor of the risk of developing preeclampsia with severe features than standard clinical measures.

By Nick Paul Taylor • May 22, 2023

Abbott gains edge over cardiac monitor rivals with FDA clearance of 6-year device

Rival devices sold by Biotronik, Boston Scientific and Medtronic have battery lives ranging from three to 4.5 years.

By Nick Paul Taylor • May 19, 2023

Rapid AI adoption could cause medical errors, patient harm, WHO warns, urging oversight

Warning that caution is not being exercised with use of artificial intelligence in healthcare, the World Health Organization called for rigorous oversight of the new technology.

By Susan Kelly • May 17, 2023