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Food and Drug Administration (FDA) FDA Approval FDA De Novo Clearance

Knobbe Martens

Orthobond Received FDA De Novo Approval for Antibacterial Technology

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Orthobond received on April 5th de novo approval for the company’s spinal fusion device with quaternary ammonium compound coating. Orthobond’s antibacterial treatment, Ostaguard™, covalently bonds its antimicrobial,...more

Faegre Drinker Biddle & Reath LLP

FDA’s Final Guidance: “Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals,...

The U.S. Food & Drug Administration (FDA) has released a final guidance document entitled, “Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications,...more

Hogan Lovells

Uncertainty remains: FDA releases new benefit-risk decision tree for medical device PMAs and De Novos in concert with final...

Hogan Lovells on

On 30 August 2019 the U.S. Food and Drug Administration (FDA or the agency) issued a final guidance document entitled "Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals,...more

Knobbe Martens

FDA Approves Marketing of Self-Fitting Hearing Aid

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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

Mintz - Health Care Viewpoints

FDA Introducing a Variety of Programs to Help Medical Devices Get to Market

Over the past couple of years, FDA has introduced multiple programs allowing faster review of medical devices in order to get them to market more quickly. Some of the FDA’s efforts have been highly visible, such as the...more

Knobbe Martens

FDA grants De Novo Market Clearance of Artificial Intelligence Software

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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

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