FDA awarded Lipogems another Investigational Device Exemption (IDE) study for the use of MicroFat for the treatment of knee osteoarthritis (OA). The second IDE study will be conducted for the safety and efficacy for the treatment of knee OA compared to saline and will include 15-20 well-respected academic and private practice orthopaedic institutions.
Lipogems is FDA cleared for use in general applications in orthopedics, arthroscopy and nine other specialties since 2014. Lipogems has worked closely with FDA to seek a separate FDA clearance for a specific indication in knee OA. While Lipogems pursues the knee OA indication, physicians may continue to use the product for the general indications specified in the existing FDA clearance.
FDA awarded Lipogems another Investigational Device Exemption (IDE) study for the use of MicroFat for the treatment of knee osteoarthritis (OA). The second IDE study will be conducted for the safety and efficacy for the treatment of knee OA compared to saline and will include 15-20 well-respected academic and private practice orthopaedic...
FDA awarded Lipogems another Investigational Device Exemption (IDE) study for the use of MicroFat for the treatment of knee osteoarthritis (OA). The second IDE study will be conducted for the safety and efficacy for the treatment of knee OA compared to saline and will include 15-20 well-respected academic and private practice orthopaedic institutions.
Lipogems is FDA cleared for use in general applications in orthopedics, arthroscopy and nine other specialties since 2014. Lipogems has worked closely with FDA to seek a separate FDA clearance for a specific indication in knee OA. While Lipogems pursues the knee OA indication, physicians may continue to use the product for the general indications specified in the existing FDA clearance.
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