J&J’s Sedasys Sedation System Now “Approvable,” Though Some Questions Remain
This article was originally published in The Gray Sheet
Outstanding FDA questions pertain to follow-up data, user training and “post-market observance and those sorts of things,” CFO Dominic Caruso told investors during the firm’s first-quarter earnings call April 17.
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In a recent interview with “The Gray Sheet,” the founding director of the Medical Device Interoperability Program describes an ongoing effort to establish a clearer FDA pathway for devices designed to seamlessly communicate with other products, even those made by different manufacturers.
J&J expects the divestiture to reduce regulatory barriers to its pending $21 billion Synthes acquisition.
Big changes are underway at J&J. In April, Alex Gorsky will become the company’s new CEO. And the firm plans a restructuring of its device business upon completion of its $20 billion-plus Synthes acquisition in the first half of the year.