12/11/2023 0 Comments Bluetail medical st. louis moBMG, with CRRI, began regular meetings with the FDA since 2019 when the latter announced the planned updates to their regulation of cellular therapies. The great news is that BMG, in conjunction with CRRI, has been working behind the scenes to emerge as the standard for an Orthopedic Regenerative Medicine practice under the new FDA Regulatory Framework. If not eventually compliant, these facilities will be closed permanently. All providers in this space must work within the updated FDA framework or they will be cited. These include Regenerative Medicine Specific Clinical Outcomes Databases, cell counts on cellular therapies, additional safety measures, and many other items. The regulators within the FDA, as well as other parties invested in the non-bio-cellular space, are mandating higher quality studies to be in place to practice Regenerative Medicine. We use this data to define our success rates with various orthopedic diseases and injuries based on age, sex etc.Īs of June 2021, the FDA has put into place a very strict but appropriate regulatory framework for all Regenerative Medicine Clinics. BMG has been formally collecting outcomes data for over 10 years. We began using a data collection system that was engineered for Orthopedic Surgeons since one did not exist at that time for Orthopedic Regenerative Medicine. A new field of medicine cannot use an evidence-based approach when no evidence yet exists!Īs we expanded our cellular therapy offerings it became imperative that BMG collect outcomes data to ensure safety and efficacy. We initially guided our treatment protocols and pathways using early clinical outcomes data and anecdotal evidence. In fact, the term “Regenerative Orthopedics” had not even been coined when our doctors started using Platelet Rich Plasma. Bluetail Medical Group (BMG) has been practicing Orthopedic Regenerative Medicine since 2004.
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |