Qiagen Launches First FDA-Approved Companion Diagnostic For Novartis’ Alpelisib
The US FDA approved Qiagen’s therascreen PIK3CA RGQ PCR kit to guide treatment of breast cancer with Novartis’ new drug Piqray (alpelisib).
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A snapshot of global medical device approvals captured during the past week in Medtech Insight's Approvals Tracker. This week's approvals include a PMA for Qiagen's therascreen PIK3CA RGQ real-time qualitative PCR assay kit as a companion diagnostic to Novartis' Piqray (alpelisib) and a de novo for Theranica's Nerivio Migra smartphone-controlled wearable device to treat migraines.
Keeping Track: Novartis Scores Big Ahead Of US Memorial Day With Approvals For Gene Therapy Zolgensma, Oncologic Piqray
Digital Surgery, a London-based developer of surgical artificial intelligence, analytics, digital education and training solutions, will join Medtronic’s surgical robotics business within its minimally invasive therapies group.