Brandon Smith

Knobbe Martens

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Latest Posts › FDA Approval

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First Thrombectomy Device Cleared for Pulmonary Embolisms

The FDA announced 510(k) clearance for Inari Medical’s FlowTriever device for the treatment of pulmonary embolism (“PE”). According to Inari, the FlowTriever system is the first thrombectomy device cleared for the treatment...more

6/8/2018 / 510(k) RTA , FDA Approval , Food and Drug Administration (FDA) , Innovation , Medical Devices , Pharmaceutical Industry

FDA Clears First Apple Watch Medical Device Accessory

The FDA recently cleared the first medical device accessory for the Apple Watch — AliveCor’s KardiaBand. According to AliveCor, the Kardiaband is a mobile, real-time electrocardiogram (EKG) reader that can record an EKG...more

12/12/2017 / Apple , Apple Watch , FDA Approval , Food and Drug Administration (FDA) , Medical Devices , Mobile Health Apps

FDA Approves Bayer’s myBETAapp™

On May 30, 2017, Bayer announced FDA approval of a supplemental Biologics License Application for Bayer’s myBETAapp™ and BETACONNECT Navigator™. The myBETAapp joins the growing field of medical mobile applications, which the...more

6/16/2017 / Bayer , Biologics , FDA Approval , IP License , Medical Devices , Mobile Health Apps , Mobile Medical Applications

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