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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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.
The US FDA approved Qiagen’s therascreen PIK3CA RGQ PCR kit to guide treatment of breast cancer with Novartis’ new drug Piqray (alpelisib).
The FDA granted a de novo clearance to Theranica’s Nerivio Migra smartphone-controlled remote electrical neuromodulation device for acute treatment of migraine headaches.