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

Medical device groups say ‘the stakes are high’ with new EtO regulations

AdvaMed, which represents medical device companies, warned that patients could face treatment delays if sterilization facilities close.

By Elise Reuter • April 11, 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

EPA to limit ethylene oxide emissions from medical device sterilizers

The agency proposed new emissions limits that device sterilization companies would have 18 months to meet.

By Elise Reuter • 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

Philips recalls 1,200 reworked sleep apnea devices over fault that can cause therapy failure

The problems keep mounting for Philips, as recently repaired respirators now need to be fixed in a recall the FDA has labeled a Class I event.

By Nick Paul Taylor • April 10, 2023

EPA proposes stricter ethylene oxide pollutant rules for chemical makers

Further EPA proposals involving medical device sterilization plants are expected to be forthcoming.

By Susan Kelly • April 7, 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

Getinge’s quality woes continue: FDA categorizes another heart pump recall as Class I event

The recall is the latest in a series of compliance problems for Getinge, which has had CE marks for two products suspended.

By Nick Paul Taylor • 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

Philips CEO Jakobs expects first settlement on respirators this year, Dutch newspaper says

Jakobs said he “hopes and expects” to reach a settlement with the Food and Drug Administration this year; settling suits over alleged medical damages may take longer.

By Peter Green • March 31, 2023

Safety of fixed palatal expanders probed by FDA amid patient lawsuits

The investigation follows lawsuits from patients who say the device damaged their teeth and gums, and eroded their jawbones. 

By Nick Paul Taylor • March 31, 2023

FDA qualifies tool for predicting temperature rise when orthopedic implants enter MRI scanners

Device makers can use the tool to identify femoral nail designs that would be less suitable for use in people who may undergo MRI.

By Nick Paul Taylor • March 31, 2023

Surmodics receives FDA feedback weeks after layoffs

Last month, Surmodics laid off 13% of its workforce, blaming regulatory approval delays, which also halted a $24 million milestone payment from Abbott as the firms work on a treatment for peripheral arterial disease.

By Susan Kelly • March 30, 2023

Getinge heart pump has CE mark suspended by second notified body, halting sales for 3 months

TÜV SÜD took the action over concerns related to risk management, post-market surveillance and vigilance, and the timeliness of field safety corrective actions.

By Nick Paul Taylor • March 28, 2023

Bill would require Medicare to cover breakthrough devices for four years

The bipartisan legislation, if enacted, would speed the coverage determination process for FDA-approved devices.

By Susan Kelly • March 27, 2023

FDA details plan to end emergency use authorizations

The agency is providing a 180-day transition period for devices that were exempted during the pandemic, and said companies that currently have an EUA should start preparing.

By Elise Reuter • March 27, 2023

Intuitive’s ecosystem means it will take J&J, Medtronic years to win surgical robot market share: analysts

The analysts expect Intuitive to retain its leadership position “even as new entrants ramp up their competitive offerings.”

By Nick Paul Taylor • March 24, 2023

Exactech implants may oxidize, FDA says, warning surgeons not to use any recalled joints

Exactech is recalling knee and total ankle replacements that were packaged in defective bags.

By Nick Paul Taylor • March 24, 2023

Delays in reporting led FDA to late cancer warning on breast implants, advocates say

Cases need to be better tracked, and the cancer risks should be discussed with patients prior to surgery, patient advocates and physicians said.

By Elise Reuter • March 22, 2023

Spine robot maker Accelus gains another FDA clearance

The company believes its Remi device, which works with several major imaging systems, can gain traction in the market with its portable design.

By Susan Kelly • March 21, 2023

J&J’s Ashley McEvoy named chair of AdvaMed

McEvoy, who is J&J’s worldwide chairman of medtech, will lead the trade association’s board for the next two years.

By Elise Reuter • March 20, 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