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

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

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

Icahn says his Illumina board candidates will ‘ask the tough questions’

The billionaire investor repeated his call for the ouster of CEO Francis deSouza in a new letter to fellow shareholders.

By Susan Kelly • May 5, 2023

Algorithm may help avoid 40% of kidney transplant rejection misdiagnoses: study

The decision-support system “could have important clinical implications for the management and treatment of transplant recipients,” researchers found.

By Nick Paul Taylor • May 5, 2023

BD raises full-year forecasts again, expects Alaris infusion pump approval

The company said revenue increases in a number of its product lines were faster than market growth rates, suggesting it’s gaining share.

By Susan Kelly • May 4, 2023

Hologic, after overcoming chip shortage, starts considering larger M&A deals

The breast health unit “emphatically returned to growth” because of improvements to the supply of semiconductors.

By Nick Paul Taylor • May 2, 2023

Great Britain proposes allowing CE marks until 2030 to minimize Brexit disruption

The extended timeline to create a new regulatory system in England, Scotland and Wales is intended to prevent medical device shortages.

By Nick Paul Taylor • May 1, 2023

Illumina gets cybersecurity warning from FDA over sequencing software

The vulnerability could result in an attacker gaining control of an instrument remotely and altering genomic data results, the agency said.

By Susan Kelly • Updated April 28, 2023

Quest Diagnostics to pay $450M to buy liquid biopsy cancer test developer as Q1 revenue drops

The laboratory services provider said patients are returning to the healthcare system for routine care, but COVID testing has plummeted as the pandemic winds down.

By Susan Kelly • April 27, 2023

Thermo Fisher reports 9% drop in Q1 revenue, shares slip

The drop in revenue accompanied a 41% decline in net income, with Life Sciences Solutions and Specialty Diagnostics revenue declining by double digits. 

By Peter Green • April 26, 2023

Illumina, under pressure from Icahn, outlines plan to reduce more expenses

The company outlined in its first-quarter earnings call a second set of cost cuts aimed at accelerating margin improvement.

By Nick Paul Taylor • April 26, 2023

GE HealthCare revenue up in first quarter as a standalone company, but shares drop

Steady demand and supply chain improvements have helped it grow the business, even as inflation and foreign exchange rates pressure its income.

By Elise Reuter • Updated April 25, 2023

Labcorp posts Q1 net decline, says Fortrea spinoff on track for mid-year

The company’s first quarter results in its base operations were boosted by a partnership to manage hospital laboratories for Ascension.

By Susan Kelly • April 25, 2023

Ending free COVID tests risks worsening the pandemic

If Americans start paying out of pocket for COVID tests, they'll test much less — if at all, argue representatives of the Testing at Home Coalition.

By Amy Kelbick and Eric Zimmerman • April 20, 2023

Illumina slaps back at Icahn’s board nominees, opens proxy collection

The fight continues as Illumina aims to block Icahn’s nominees from ousting its CEO and board chair.

By Peter Green • April 20, 2023

Abbott hit with FDA warning letter over unapproved changes to heart disease test

The FDA said that four changes made to the tests “could significantly affect the safety or effectiveness of the devices.”

By Nick Paul Taylor • Updated April 20, 2023