J&J’s Sedasys Sedation System Now “Approvable,” Though Some Questions Remain

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.

Ethicon Endo-Surgery Inc. is working to respond to FDA questions about follow-up data and training materials following receipt of a recent “approvable” letter for its Sedasys computer-assisted personalized sedation system, the company disclosed April 17 during its first-quarter earnings call.

The Johnson & Johnson subsidiary received the approvable letter in February, “and we need to respond to the requirements...

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