Senseonics expects FDA panel to consider Eversense CGM clearance

Senseonics (NYSE:SENS) said it expects the FDA will convene a special panel as it considers the company’s implantable Eversense continuous glucose monitors. The clarity came during the company’s 2nd quarter earnings call last week, with CEO Tim Goodnow saying the company expected the federal watchdog to look to an advisory panel, similar to its actions with Dexcom‘s (NSDQ:DXCM) G5 non-adjunctive approval last year. “In the United States, our PMA application continues to be evaluated by the FDA and we are in active discussions with the agency and are responding to inquiries in earnest. As we have said previously, Eversense is a novel product and is the first of a kind as a long-term implantable sensor. It is our belief that the agency will convene an advisory panel to explore the communities’ feedback on the safety elements of an implantable sensor as well as the training programs designed to introduce endocrinology, diet/pathology professionals to the in-office procedures of sensor placement. This process will allow the interested medical community to comment on an implantable product,” CEO Goodnow said, according to a SeekingAlpha transcript of the call. The Eversense system includes an implanted glucose sensor designed to last up to 90 days, as well as a wearable smart transmitter designed to calculate glucose levels. The devices work in tandem with a mobile application that allows for the real-time display of glucose readings, the company said. Sense...
Source: Mass Device - Category: Medical Devices Authors: Tags: Diabetes Food & Drug Administration (FDA) Regulatory/Compliance Senseonics newtag Source Type: news