Singapore, April 13 -- Miracell, a South Korea-based stem cell technology company, has obtained US FDA 510(k) clearance for its stem cell extraction system, SMART M-CELL, along with its dedicated kits, the BSC Blood Kit and BMSC Bone Marrow Kit.

The clearance was granted based on demonstrated substantial equivalence to SmartPReP, a globally recognised standard system originally developed by the Institute for Immunological Research (IDI) at Harvard Medical School.

The cell concentration technology utilising SmartPrep has been continuously validated through a wide range of studies and comparative analyses, with approximately 100 related publications and review articles reported to date.

Beyond musculoskeletal indications, the biological ...