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 • May 31, 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 May 31, 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

Icahn bolstered by another proxy advisor in battle with Illumina

The DNA-sequencing company defended its board chair, John Thompson, and drew attention to a new disclosure that Icahn’s firm is being investigated by the U.S. attorney for the Southern District of New York.

By Susan Kelly • Updated May 15, 2023

Philips agrees to pay SEC more than $62M to settle China corruption charges

Resolving charges that employees, distributors and subsidiaries may have engaged in improper bidding in China lets Philips put the issue behind it without admitting guilt.

By Susan Kelly • May 12, 2023

GE HealthCare’s order book raises questions about sales-growth potential, analysts say

BTIG analysts found “lower order growth than what is assumed” and shared concern the medtech company may face challenges just four months after it was spun off from parent General Electric.

By Nick Paul Taylor • May 12, 2023

Icahn wins proxy firm nod to oust CEO from Illumina board

The recommendation from Glass Lewis is a boost for Icahn’s plan to force change at the DNA sequencer, as he and Illumina’s management battle for proxies ahead of a shareholder vote on May 25.

By Elise Reuter • May 11, 2023

Google adds image analysis capabilities to generative AI model, enabling dialogues with doctors

The Med-PaLM 2 has the ability to review X-rays and mammograms, write reports about images and respond to follow-up questions from caregivers.

By Nick Paul Taylor • May 11, 2023

Thermo Fisher, Pfizer partner to boost NGS cancer testing outside U.S.

The agreement is expected to increase access to next-generation sequencing for patients in more than 30 countries.

By Susan Kelly • May 10, 2023

Guardant blood test detects 83% of colorectal cancer cases, but fewer in early stage

Analysts said the test is likely to meet the bar for FDA approval, but its flaws in detecting early-stage cancer weaken its chances against Exact Sciences’ stool-based test, Cologuard.

By Elise Reuter • May 10, 2023

Illumina defends its board, calls Icahn campaign ‘character assassination’

The activist investor’s plan shows a lack of understanding of the company and  genomics industry, the maker of DNA sequencers said.

By Susan Kelly • May 8, 2023