Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

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

This article was originally published in The Gray Sheet

Executive Summary

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.

You may also be interested in...



Piecing Together The Interoperability Puzzle: Q&A With Julian Goldman

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.

Biomet Offers $280 Mil. For J&J’s DePuy Trauma Biz; Bid Facilitates Synthes Deal

J&J expects the divestiture to reduce regulatory barriers to its pending $21 billion Synthes acquisition.

J&J Eyes Restructured Device Biz As New CEO Gorsky Steps In

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.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

MT031157

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel