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OUS Approvals Analysis: November Product Go-Aheads Headlined by LimFlow, Abbott, Creavo

 
• By Reed Miller

The number of medical device approvals reported outside the US rebounded in November after a very slow October. There were 14 CE marks, three approvals in Japan, and three in Canada last month, covering nine different product categories.

International Flags Blowing In Wind_1200x675

[Editors' note: For sortable and searchable tables of all 2016 US and non-US approvals and clearances, check out ourApprovals Tracker.]

A unique percutaneous system that creates an arterio-venous fistula to restore blood supply to an ischemic foot leads November's crop...

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• By Shubham Singh

Roche has taken steps to mitigate potential tariff exposure that include shifting inventories and increasing US production of medicines. The company also initiated a tech transfer for one of its most exposed products to a US manufacturing site.

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• By Ashley Yeo

The Lioness non-surgical silicon ring implant is designed to put an end to pre-term births, sparing maternal anguish and saving health system costs. PregnanTech won the Biomed Israel 2025 medtech start-up award, and Limor Sandach told In Vivo how a non-digital technology beat off stiff competition.

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• By Natasha Barrow

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