Shots:
- The US FDA has granted 510(k) clearance to Miracell’s SMART M-CELL PRP Concentration System and Bone Marrow Concentration System, including associated blood and bone marrow kits
- Clearance was based on substantial equivalence to SmartPReP, with the system demonstrating high cell viability, efficient growth factor extraction, and integrated performance across centrifuge and kit components
- SMART M-CELL is designed to isolate and concentrate growth factors and multi-cell components to support tissue regeneration across musculoskeletal, wound healing, and regenerative medicine applications
Ref: PR Newswire | Image: Miracell | Press Release
Related News: Anumana Secures the US FDA 510(k) Clearance for its ECG-AI Algorithm to Detect Risk of Cardiac Amyloidosis Early
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