News We’re Watching – 20 January
Executive Summary
This new Medtech Insight feature compiles news briefs on a range of US regulatory and legal happenings. This week: Congressional criticism of ClinicalTrials.gov, new radiation device performance standards, clearance of a new sepsis test and two new device classifications.
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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.
Q&A Guidance Document Discusses Laser Product How-Tos
Products like laser pointers, gun sights and lasers used to align machinery fall under a new guidance document from the US FDA, which details the limits on how much radiation these products may emit.
News We're Watching – 27 January
This feature compiles news briefs on a range of US regulatory and legal happenings. This week: Medtronic seeks HeartWare batteries; companies sign health equity pledge; insulin dosing app cleared; recall on field decontamination kits; and the renewal of an FDA panel.