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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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Device Sterilization Plants Get Extra 2 Years To Comply On EtO Phase-Out

 
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The exemption, which President Donald Trump announced on July 17, is intended to cut the risk of critical device shortages. Stakeholders say the technology needed to cut emissions to required levels is not yet widely available.

Numerous Injuries Prompt Class I Recall Of Dexcom CGM Receivers

 
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Experts Call For Database Of Medical Device Labels

 
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EU Authorities Unite In Call For Urgent Overhaul Of Medtech Regulations

 
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EU member states have issued a consensus statement on the urgent need to build momentum to tackle governance and centralization issues as part of much-needed reform of the EU medtech regulatory system.

More from Recalls

A Year After Exiting The Ventilator Market, Medtronic Recalls Thousands Of Newport Devices

 
• By Brian Bossetta

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FDA Rebukes Four Companies, Including One Overseas, For Procedural Failures

 
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California Medtech Firms Resolve Patent Dispute Over Delivery Catheters

 
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