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.
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US FDA Greenlights First-In-Kind Diagnostics, Device
The US Food and Drug Administration recently approved several first-of-a-kind diagnostics and a medical device, including a test kit for prosthetic joint infections, a Zika virus test and an electric field device to treat cancers.
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).
Theranica’s Smartphone-Controlled Migraine Device Earns FDA De Novo
The FDA granted a de novo clearance to Theranica’s Nerivio Migra smartphone-controlled remote electrical neuromodulation device for acute treatment of migraine headaches.