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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. 

Medtronic Adds UK-Based Digital Surgery To Support Robotic Surgery

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.

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