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Discontinued Endologix AAA Graft Device Singled Out In Updated FDA Alert

 
• By David Filmore

US FDA says that previously identified elevated risks of type III endoleaks from endovascular aneurysm repair systems appears to be linked to a specific, no-longer-sold device, Endogix's AFX with Strata system.

Last fall, FDA circulated findings that rates of a particular type of adverse event were higher than expected for endovascular graft systems intended to repair abdominal aortic aneurysms (AAA). Now the agency says the problem appears to be linked only to one specific device that was previously removed from the market.

Endovascular aneurysm repair (EVAR) devices are intended to exclude the AAA sac from the arterial circulation and prevent the aneurysm from rupturing

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FDA Announces Classifications On 8 Device Types

 
• By Elizabeth Orr

The US Food and Drug Administration has announced new classifications for eight device types that reached market via the de novo process, with most of the newly classified products in the diagnostics sector.

Medical Devices Not The Focus Of FDA’s Plans To Step Up Foreign Inspections, Expert Says

 
• By Brian Bossetta

The US FDA recently announced plans to carry out more unannounced inspections of foreign facilities. But those inspections will primarily target drug producers, with less attention and resources allocated to those making devices.

Faster Device Certification Among Keys To Unlocking Innovation In EU MedTech Sector

 
• By Amanda Maxwell

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Consumer Healthtech Investment Totaled $4.5BN In 2024, But Bar Is High Amid Economic Uncertainty

 
• By Marion Webb

Global investment in consumer healthtech increased by 9% year-over-year in 2024, totaling $4.5bn, with significant interest in mental health solutions, according to Galen Growth. While the first quarter of 2025 saw raised confidence and investments, the Trump administration’s new tariffs and sweeping changes to healthcare have introduced new uncertainties.

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