Avoid These Headaches During Regulatory Submissions
Here are some tips on how to avoid deficiencies during final submissions, particularly those involving biocompatibility data.
New Approval Helps Implanting Propel Mini a Little Bit Easier
The Menlo Park, CA-based company said it has received a nod from FDA for the Straight Delivery System for use to place its Propel Mini Steroid implant.
Medtronic Looks to Expand Reach of Artificial Pancreas with New Submission
The Dublin-based company filed a PMA submission to FDA requesting for non-adjunctive labeling for the Guardian Sensor 3, as part of the MiniMed 670G system.
FDA Flips the Switch on Pelvic Mesh Manufacturers
FDA has ordered Boston Scientific and Coloplast to stop selling surgical mesh intended for transvaginal repair of pelvic organ prolapse. Patient advocates say the action was not made soon enough and does not go far enough, but it is a step in the right direction.
Dirty Scopes Are Still a Big Problem
FDA-mandated studies indicate higher than expected levels of contamination on duodenoscopes after reprocessing.
