Lindsay Laddaran

Lindsay Laddaran

Knobbe Martens

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Latest Posts › Food and Drug Administration (FDA)

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FDA Approves Marketing of Self-Fitting Hearing Aid

The U.S. Food and Drug Administration recently announced approval for Bose to market their Bose Hearing Aid. According to the press release, the Bose Hearing Aid, which was approved through the FDA’s De Novo premarket review...more

11/14/2018  /  FDA Approval , FDA De Novo Clearance , Food and Drug Administration (FDA) , Marketing , Medical Devices

FDA grants De Novo Market Clearance of Artificial Intelligence Software

According to a U.S. Food and Drug Administration press release, Viz. AI Contact application was granted De Novo premarket review to Viz.AI’s LVO Stroke Platform. According to PR Newswire, Viz.AI’s LVO Stroke Platform is the...more

4/10/2018  /  Artificial Intelligence , FDA Approval , FDA De Novo Clearance , Food and Drug Administration (FDA) , Medical Devices , Premarket Approval Applications , Software
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