FDA Panel To Decide If Adept Adhesion Prevention Device Is True To Its Name
This article was originally published in The Gray Sheet
Executive Summary
FDA's Obstetrics & Gynecology Devices Panel will consider Innovata's Adept for preventing gynecological laparoscopic surgery-based adhesions at a March 27 meeting in Gaithersburg, Md
You may also be interested in...
Ob/Gyn Panel Unanimously Supports Adhesion-Prevention Product Approval
Baxter's biosurgery business stands to gain from an FDA advisory panel's unanimous support for a product designed to prevent a serious side effect of certain surgical procedures. But limitations recommended for the label could curb some of the market potential if adopted by the agency in its final approval decision
Ob/Gyn Panel Unanimously Supports Adhesion-Prevention Product Approval
Baxter's biosurgery business stands to gain from an FDA advisory panel's unanimous support for a product designed to prevent a serious side effect of certain surgical procedures. But limitations recommended for the label could curb some of the market potential if adopted by the agency in its final approval decision
Confluent Eyes Untapped $200 Mil. Neurosurgery Market For DuraSeal
Confluent Surgical expects PMA approval by year-end for its DuraSeal sealant for prevention of cerebrospinal fluid (CSF) leaks in neurosurgery procedures, according to CEO Amar Sawhney