Lipogems® is CE marked, approved by the FDA and certified by the Istituto Superiore della Sanità (Italian Health Authority) and the National Transplant Center.
America
FDA USA 510K
Europe
CE MarkMiddle East
FDA Saudi ArabiaLocal registrations
Japan
PMDAOceania
ARTG CertificateTGA Certificate
The new FDA 510K
Explains:
the new FDA authorization includes the same previously approved clinical applications and further clarifies that the Lipogems® device is used for washing, reducing, micro-fragmenting and concentrating adipose tissue. The new authorization also specifies that the Lipogems® process is “minimal manipulation of adipose tissue” by clearly defining the opinion of the FDA.
Expands:
The new approval broadens the indications of Lipogems® in arthroscopy (eg minimally invasive joint surgery).
Defines:
The previous authorization established that during the procedure the device keeps the vasculo-stromal niche intact . The new Lipogems® authorization adds that the procedure preserves the micro architecture of tissue and cells.
The National Transplant center
The legal opinion of July 15, 2015 (protocol 2515 / CNT2015), has classified the processed Lipogems product as adipose tissue intended for autologous grafting, specifying that the function exerted by the transplanted tissue is the same as that exercised in the original site.
This opinion was followed by the approval – December session 13, 2016 – by the Istituto Superiore Di Sanità (Rome ISS-CNT / 24/02 / 2017-0000597) of the randomized controlled trial currently being held at the Rizzoli Orthopedic Institute of Bologna.