Lipogems announced it has received an FDA 510(k) clearance for expanded indications and labelling of its Lipogems System for adipose tissue transfer.
According to a company press release, the system offers a single-use, disposable device that processes autologous adipose tissue to fill soft tissue defects. The new clearance from the FDA further defines the indications of the device to harvesting, concentrating and transferring autologous adipose tissue. It also expands the indications of the system into the field of arthroscopy. According to the release, the new FDA clearance notes the system preserves both the cell and tissue microarchitecture of the adipose tissue and “provides a tissue that is minimally manipulated in accordance with FDA guidelines for Human Cell and Tissue Products.”