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News We’re Watching: Senators Call For Recall Info, TriClip Gets Panel Date

 
• By Brian Bossetta and Elizabeth Orr

This week, US Senators Dick Durbin and Richard Blumenthal asked a government watchdog to review the FDA’s device recall authority; the FDA announced a panel date for Abbott’s MitraClip; and the DermaSensor skin cancer detection tool got FDA authorization.

Regulatory News We're Watching
• Source: Shutterstock

Citing reporting from the Pittsburgh Post-Gazette and ProPublica, US senators Dick Durbin, D-IL, and Richard Blumenthal, D-CT, are calling for the Government Accountability Office (GAO) to review the FDA’s oversight of medical device recalls.

The senators reference news reports that say Philips Respironics failed to submit timely and comprehensive adverse event reports on his CPAP breathing machines, which have

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News We’re Watching: New FDA Approvals For Breast Implant, Colon Cancer Test, Imaging Agent; TAP Expansion, AI Standards

 
• By Brian Bossetta, Marion Webb, Elizabeth Orr, and Natasha Barrow

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News We’re Watching: Neuralink’s Blindsight Gets FDA Breakthrough Device Tag; FDA Pump Recalls, Guidances; Discure, DeepLook Bolster Coffers

 
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