FoundationOne Nabs US FDA Approval As Companion Diagnostic For Rare Cancers
The approval is the 25th indication for the diagnostic, but the first for any companion diagnostic to Roche’s Rozlytrek.
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Foundation Medicine and Novartis’ commercial partnership has achieved another success as Foudation’s Liquid CDx is approved.
The ENT specialist reportedly purchased only 36 single-use sinus devices but performed at least 1,400 procedures. She could land up to 40 years in prison after being convicted on 20 counts including device adulteration, conspiracy, and fabricating medical records.
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.