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

Abbott boosts organic sales outlook as device demand accelerates

A rebound in surgical procedure volumes as hospital staffing improved at the start of the year partially offset a steep drop in COVID-19 testing sales.

By Susan Kelly • April 19, 2023

Genomics companies Ultima, Genome Insight partner to offer low-cost sequencing

Genome Insight will develop whole genome bioinformatics for Ultima’s sequencing instrument platform under the agreement.

By Susan Kelly • April 14, 2023

Illumina-Icahn proxy battle heats up as Grail divestment orders loom

DNA-sequencing provider Illumina is headed for a showdown with billionaire financier Carl Icahn over three of nine seats on its board of directors as it continues to defy regulators’ orders to divest cancer test maker Grail.

By Susan Kelly • April 12, 2023

Function Oncology raises $28M to use CRISPR to tailor cancer diagnosis and treatment

The startup says its genomics platform can improve on conventional sequencing by uncovering drug target vulnerabilities directly in patient tumor samples.

By Nick Paul Taylor • April 12, 2023

Icahn pushes for spinoff of Illumina’s Grail liquid biopsy unit

The billionaire financier, who is waging a proxy fight for seats on Illumina’s board, is arguing that Grail should become a standalone publicly traded company.

By Susan Kelly • April 11, 2023

Medtech buyouts by private equity in Q4 shed light on deal-making trends in 2023: report

Medtech companies are continuing to spin off assets to realign portfolios, creating opportunities for private equity firms to buy businesses and exit existing investments.

By Nick Paul Taylor • April 11, 2023

Illumina backs its board in proxy fight with Icahn

Illumina directors up for re-election to one-year terms include prominent leaders in healthcare such as former FDA Commissioner Scott Gottlieb and longtime Intuitive Surgical CEO Gary Guthart.

By Susan Kelly • April 10, 2023

Friday Q&A: Fujifilm’s Henry Izawa on navigating a tough hospital equipment market

The CEO of Fujifilm Healthcare Americas discusses integrating Hitachi’s diagnostic imaging business, new product launches and how hospital budgets are changing the market for imaging.

By Elise Reuter • April 7, 2023

Icahn ramps up rhetoric on Illumina after FTC orders Grail sale

In a letter to Illumina shareholders, Icahn says the two companies “should be separated immediately” to protect “long term growth prospects.”

By Peter Green • April 5, 2023

Diagnostics execs charged with concealing lead test flaw

The former CEO and two other top executives of Magellan Diagnostics are accused of hiding a malfunction that caused tens of thousands of children and adults to receive inaccurately low lead test results.

By Susan Kelly • Updated April 5, 2023

Diagnostic testing reform bill has a path to the finish line this year: AdvaMed

Legislators recently reintroduced the VALID Act, which would bring lab-developed tests and in-vitro diagnostics under one framework, after failing to pass the bill twice last year.

By Elise Reuter • Updated April 5, 2023

Why won’t Illumina sell Grail?

While financier Carl Icahn and regulators in the U.S. and Europe want DNA-sequencing company Illumina to divest liquid biopsy company Grail, Illumina’s board won’t budge. Analysts say they may be waiting for the best moment.

By Susan Kelly • April 4, 2023

Masimo receives De Novo nod from FDA for device designed to detect signs of opioid overdose

The system detects patterns associated with opioid-induced respiratory depression and sends alerts that escalate in line with the risk level.

By Nick Paul Taylor • April 4, 2023

Illumina ordered to divest Grail by FTC on anticompetition concerns

The San Diego-based DNA-sequencing company, which also faces a challenge from European antitrust regulators, said it will appeal the FTC’s order.

By Susan Kelly • April 3, 2023

Illumina urges shareholders to reject Icahn board nominees

The DNA-sequencing company says Icahn’s board nominees don’t understand its business or the regulatory process.

By Susan Kelly • March 31, 2023

Potential to improve early cancer detection lands Elypta prize inspired by Star Trek creator

The metabolism-based liquid biopsy improved on the ability of genomic tests to detect stage I cancers in a recent study.

By Nick Paul Taylor • March 30, 2023

Breast cancer AI company iCAD lays off workers, names new CEO

The company, which reported a net loss on Tuesday, is also exploring strategic alternatives for its Xoft therapy business.

By Susan Kelly • March 29, 2023

Qiagen’s Thierry Bernard named chair of the AdvaMedDx board

Thierry Bernard, the CEO of Qiagen, succeeds Norman Schwartz, CEO of Bio-Rad Laboratories, in leading the diagnostics division of trade association AdvaMed.

By Susan Kelly • March 28, 2023

AntennaWare secures patent for wireless tech designed to unlock implant applications

AntennaWare sees the technology facilitating deep-tissue implants that unlock new ways to monitor and treat disease.

By Nick Paul Taylor • March 27, 2023

Icahn says Illumina directors got personal insurance after Grail deal

The extra liability coverage shows the directors feared unspecified consequences from closing the acquisition of Grail, according to the activist investor.

By Susan Kelly • Updated March 24, 2023

Roche, Lilly team on test for early detection of Alzheimer’s

The tool is intended to help gauge whether patients should receive further evaluation to confirm a diagnosis.

By Susan Kelly • Updated March 22, 2023

Illumina, facing Icahn challenge, ‘moving quickly’ on resolution for Grail

The DNA-sequencing company said the activist investor hasn’t offered any better solutions for satisfying regulators’ concerns about the acquisition.

By Susan Kelly • March 20, 2023