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Aegera Therapeutics, Inc.

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Latest From Aegera Therapeutics, Inc.

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Microbot Medical CEO Harel Gadot said a recent regulatory filing marks an important milestone in his company' efforts to bring the world’s first fully disposable endovascular robot to market.

Robotic Surgery Robotics

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J&J’s entry into the kidney stone management market will not threaten Boston Scientific’s leadership position in that market in the near-term, according to Wells Fargo analyst Larry Biegelsen.

FDA Approvals

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Public Citizen’s request to place gabapentin on DEA’s controlled substances list may be a test case for how much weight FDA plans to give to broader public health impacts of drug approvals as opposed to the risk-benefit calculus for individual patients for whom a drug is labeled.

Drug Safety Risk Management

Device Classifications: US FDA Orders Special Controls For Treatments For ADHD, Weight Loss, More

The device classification announcements include four class II devices, as well as one that was placed in class I.

Regulation Review Pathway
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