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.

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.

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.

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