Lifecore Intergel Approvable Despite FDA Objections, MDDR Panel Says
This article was originally published in The Gray Sheet
Executive Summary
Lifecore Biomedical's Gynecare Intergel adhesion prevention solution appears closer to FDA approval following a determination by the agency's Medical Devices Dispute Resolution Panel (MDDRP) that the firm demonstrated a statistically significant treatment effect.
You may also be interested in...
Acorn Asks For More Help From Investors After FDA Panel Denies CorCap PMA
Acorn Cardiovascular says it will ask its current investors to fund a confirmatory trial of its CorCap Cardiac Support Device after an FDA advisory panel decided more research is needed before it could support premarket approval
Acorn Asks For More Help From Investors After FDA Panel Denies CorCap PMA
Acorn Cardiovascular says it will ask its current investors to fund a confirmatory trial of its CorCap Cardiac Support Device after an FDA advisory panel decided more research is needed before it could support premarket approval
Cyberonics Banking On Appeals To Avoid VNS Randomized Trial Requirement
Cyberonics will defer a new randomized trial of its VNS Therapy depression indication until it can determine whether an appeal of FDA's recent not-approvable decision may be successful