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Airiver Medical wins FDA IDE for pulmonary drug-coated balloon

Oklahoma City · Oklahoma City

Airiver Medical wins FDA IDE for pulmonary drug-coated balloon

100% Center coverage: 6 sources

The Airiver Medical drug-coated balloon. [Image from the company website] Airiver Medical announced today that it received FDA investigational device exemption (IDE) for its pulmonary drug-coated balloon (DCB). The Brooklyn Park, Minnesota-based company designed its DCB to treat central airway stenosis. This FDA IDE – the company’s first — allows it to begin a pivotal clinical trial of the technology. Central airway stenosis (airway narrowing) c…See the Story

Contivue Port Delivery Platform for nAMD Receives CE Mark

Contivue Port Delivery Platform for nAMD Receives CE Mark

Roche's Contivue platform gains EU CE mark, offering innovative treatment for neovascular AMD with fewer injections and promising long-term vision outcomes.See the Story

Senseonics to Take Over Eversense 365 Commercialization From Ascensia – RamaOnHealthcare

United States · United States

Senseonics to Take Over Eversense 365 Commercialization From Ascensia – RamaOnHealthcare

What You Should Know: – Senseonics Holdings, a medical technology company specializing in implantable continuous glucose monitoring (CGM) systems, has announced a Memorandum of Understanding (MOU) with Ascensia Diabetes Care to transition all global commercialization and distribution of its Eversense 365 and future products to Senseonics. Since 2020, Ascensia, a member of PHC Group, has [...]See the Story

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