Report names connected medical devices with the biggest cybersecurity risks

The findings come as medical device makers face upcoming FDA requirements for providing cybersecurity information as part of their pre-market submissions.

By Nick Paul Taylor • April 21, 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

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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

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

Fresenius flags fault with infusion system acquired last year in $240M deal

Fresenius noted a problem with the devices that can cause loss of power, potentially delaying or interrupting the supply of critical fluids and medications. 

By Nick Paul Taylor • April 20, 2023

Post-approval modification of high-risk devices linked to 30% jump in recall risk: study

The authors suggest improved post-marketing surveillance systems may be needed to mitigate risks to patient safety.

By Nick Paul Taylor • April 18, 2023

Zimmer’s ‘smart knee’ implant may qualify for new technology payments from CMS

If finalized, the add-on payments would help cover the cost of the sensor technology included in the company’s Persona IQ knee implants.

By Elise Reuter • April 12, 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

FDA starts device sterilization pilot program to help industry adapt to EtO emission clampdown

The FDA “recognizes the need to facilitate more timely changes” amid a push to cut EtO emissions and constraints on the supply of radioactive cobalt.

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

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

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