This article was originally published in The Gray Sheet
Executive SummarySyosset, New York firm submits 510(k) application to FDA for clearance to market its Cardiac View transesophogeal MRI receiver coil to aid in the production of MRI images of the heart and coronary vessels. The non-invasive device consists of an MRI micro receiver coil, which is encased in a probe and inserted down the throat or nasal passages of the patient into the esophagus, placing it directly behind the heart
You may also be interested in...
Submission surge in late 2019 means a spike in late summer 2020 user fee goals, including 16 novel agents in August alone.
Keeping Track: Approvals For Tazverik And Tepezza, Priority Reviews For Belantamab Mafodotin And Lynparza
The latest drug development news and highlights from our US FDA Performance Tracker.
Accelerated approval in epithelial sarcoma may de-risk the firm’s goals for approval of Tazverik in follicular lymphoma and other larger indications.