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.
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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.
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.
In this edition of Device Week, Medtech Insight's managing editor Marion Webb talks with deputy editor Reed Miller about his recent story on Abiomed's plan to counter unfavorable studies of its Impella heart pump.
[Editor's note: This article was updated on 14 February 2020 to clarify that Abiomed has invested more than $100m over the past five years in clinical research on the Impella heart pump platform. Abiomed has not committed to spend another $100m on new physician education and communication programs.]