Regulatory Sports Medicine Organogenesis Announces Successful FDA Meeting and Plan to File BLA for ReNu® for Knee Osteoarthritis Pain byTim AllenDecember 15, 2025
Extremities Regulatory Inside information: Bioretec has been granted FDA Breakthrough Device Designation status for its RemeOs™ DrillPin byTim AllenDecember 15, 2025
Biologics Regulatory Spine BioRestorative Granted Type B Meeting with FDA to Discuss Accelerated BLA Approval Pathway for BRTX-100 in Chronic Lumbar Disc Disease byJosh SandbergNovember 17, 2025
Recon Regulatory Zimmer Biomet Announces FDA Breakthrough Designation for World’s First Iodine-Treated Total Hip Replacement System byTim AllenOctober 28, 2025
Neuro Regulatory CND Life Sciences is Granted FDA Breakthrough Device Designation for Its Skin Biopsy-Based Syn-One Test® byNoah SimmonsOctober 7, 2025
Biologics Regulatory Rocket aborts mission to get gene therapy approved by FDA for rare bone marrow disorder byWill SandbergOctober 3, 2025
Regulatory FDA halts new device submissions during government shutdown byWill SandbergOctober 2, 2025
Regulatory As shutdown begins, FDA to stop accepting new drug submissions byWill SandbergOctober 1, 2025
Regulatory Envoy Medical Advances Commercialization Planning for Breakthrough Hearing Device as FDA Clinical Trial Remains On Track byWill SandbergSeptember 26, 2025
