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Qiagen Launches First FDA-Approved Companion Diagnostic For Novartis’ Alpelisib

Executive Summary

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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Global Device Approvals Snapshot: 21-28 May 2019

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

The latest drug development news and highlights from our US FDA Performance Tracker. 

Acclarent Expects TruDi Shaver Blade To Prevent Repeat ENT Surgeries

The FDA recently cleared the TruDi Shaver Blade, an electromagnetically navigated blade for the incision and removal of soft and hard tissue or bone in ear, nose, throat, and maxillofacial surgery, as well as head and neck and skull-base surgery.

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