J&J Gets Second Chance At Sedasys Sedation Device Approval
This article was originally published in The Pink Sheet Daily
Executive Summary
Subsidiary Ethicon Endo-Surgery has received a go-ahead from the FDA commissioner's office to embark on a rarely used process to appeal a PMA denial by the agency's device center.
You may also be interested in...
J&J Appeals FDA "Not-Approvable" Letter For Sedasys Sedation System
Ethicon Endo-Surgery is appealing a recent FDA "not approvable" letter for its Sedasys computer-assisted personalized sedation system
J&J’s Computer-Assisted Sedation System Gets FDA Panel Nod
Ethicon Endo-Surgery's Sedasys computer-assisted personalized sedation system should be approved by FDA, as long as labeling requires a three-person team to be present during its use, according to the agency's Anesthesiology and Respiratory Therapy Devices panel
Cancer-Genomics Firm Quanticel Debuts With Close Ties To Celgene, And An Exit In Mind
Celgene will get exclusive use of Quanticel's single-cell genomic analysis to tweak its clinical pipeline, and it also has exclusive options to acquire the venture-backed start-up.