Class I Recall For BD Intraosseous Infusion System
The US FDA has labelled a recall of Becton Dickinson intraosseous needle set kits, manual driver kits, and powered drivers as class I, its most severe designation.
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In this second roundup of HLTH, which drew more than 9,000 attendees to Las Vegas from 13-16 November, Medtech Insight highlights presentations from the CEOs of BD and Google Cloud and insights from an interview with BD’s CEO Tom Polen.
News We’re Watching – LivaNova And Medtronic Recalls; Approvals For Abbott And Guardant; Pediatric Device Grants
Recalls on a life-support device used during heart surgery and dialysis tubing were announced this week, as were approvals for a breast cancer companion diagnostic and two cardiac ablation catheters. Additionally, the US FDA has grants available for groups that assist in pediatric device development.
The omnibus spending bill passed at the end of 2022 requires clinical trial sponsors to submit a diversity action plan to the US Food and Drug Administration. Attorney Faraz Siddiqui, who coauthored a blog post on the new regulation, spoke to Medtech Insight about the requirement and the push to increase diversity.