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BD Catheter For Removing Arterial Plaque Linked To Deaths In FDA Early Alert

 
• By Brian Bossetta

While communications from the FDA have been scant since the presidential transition, early alerts from the agency’s device center are flowing again. The most recent alert includes an issue with numerous injuries and four deaths associated with a device used during cardiac procedures.

The US Food and Drug Administration has posted a series of safety alerts in the past week as part of the device center’s ongoing recalls communications pilot.

The Center for Devices and Radiological Health (CDRH) announced the pilot in November to streamline...

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FDA Changes Fail To Diminish US Appeal To European Medtech Industry

 
• By Amanda Maxwell

Despite staffing cuts and uncertainty at the FDA, the US still offers EU medtech firms stronger regulatory support, regulatory expert Bassil Akra told Medtech Insight. This is especially valued as EU rules are often viewed as overly stringent, unclear and difficult to follow.

Cardiology And PTA Procedures In Germany’s Expanded Hybrid DRGs List 2026

 
• By Ashley Yeo

2026 reimbursement calculations for the list of hybrid DRGs – a mechanism to incentivize day cases over inpatient surgery – will be issued in few weeks’ time. The medtech industry has made its demands known.

Biden-Era Device Trial Snapshot Pilot Halted Amid DEI Policy Shift

 
• By Elizabeth Orr

The FDA's Device Clinical Trial Snapshot Pilot, aimed at increasing trial transparency and diversity, has been canceled following President Trump’s anti-DEI executive order. Critics warn this may hinder trial transparency, impacting public health and demographic data accessibility.

Warning Letters - July 2025

The US FDA posted three warning letters in July, covering medical supply kits, wearables and orthopedics.

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