FDA starts review after study finds Boston Scientific's Watchman is riskier in women

FDA starts review after study finds Boston Scientific's Watchman is riskier in women

Source: 
Medtech Dive
snippet: 

FDA is evaluating a registry study that linked Boston Scientific's Watchman to a significantly higher risk of in-hospital adverse events in women compared to men. The agency is working with manufacturers of left atrial appendage occlusion devices, a market fought over by Boston Scientific and Abbott Laboratories, to assess other data sources before deciding on next steps.