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

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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

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

FDA sets end date for raft of COVID-related shortages that began early in pandemic

Shortages of home-use ventilators and clinical sample concentrators are expected to continue.

By Nick Paul Taylor • March 20, 2023

Medtech trade group pushes UK to support ambitious Software as a Medical Device program

Reams of data collected by the National Health Service, paired with advanced work in artificial intelligence at U.K. universities, could make Britain a digital health leader if the government acts. 

By Nick Paul Taylor • March 15, 2023

QuidelOrtho COVID test is first to win FDA nod via premarket review

Special controls instituted by the FDA as part of the De Novo assessment pave the way for other tests to come to market without pandemic-era Emergency Use Authorization.

By Nick Paul Taylor • March 9, 2023

Abbott gets FDA nod on lab blood test for concussion

Results are available in about 18 minutes and can rule out the need for a CT scan if negative, the company said.

By Susan Kelly • March 8, 2023

iRhythm, fighting Boston Scientific for market share, shows cardiac monitor beats rivals

An analysis of Medicare claims data found iRhythm Technologies’ Zio XT outperforms other ambulatory cardiac monitors.

By Nick Paul Taylor • March 8, 2023

Phone app tracks cough frequency in tuberculosis trial, opening up monitoring opportunity

If validated in further studies, the work could further expand the use of smartphones as diagnostic tools, particularly in areas where there are few medical professionals, and could help stop overtreatment of TB.

By Nick Paul Taylor • March 6, 2023

FDA moving ahead with rulemaking on lab developed tests without waiting for Congress: BioWorld

A senior FDA official said the agency cannot “just stand by” given the failure of Congress to pass legislation addressing regulation of the increasingly complex tests.

By Nick Paul Taylor • March 2, 2023

Remote patient monitoring increasingly popular, even as pandemic eases, analysis of insurance claims shows

Cardiologists are the main users of RPM devices, with blood pressure diagnoses accounting for more than half of all claims made in 2021. Diabetes, which accounts for 16% of claims, is the next most active area.

By Nick Paul Taylor • March 2, 2023

AdvaMed unveils policy priorities with focus on breakthrough device coverage, global market access

Congress should also prioritize protecting the medtech manufacturing supply chain and enact diagnostic testing reform, the lobbying group said in releasing a set of nine policy goals.

By Susan Kelly • March 1, 2023