The MagDI™ System by GT Metabolic is a magnetic compression anastomosis device designed to create a side-to-side duodeno-ileal anastomosis in minimally invasive and laparoscopic surgery. This article explains what magnetic compression anastomosis is and exactly what the FDA has authorized.
What is magnetic compression anastomosis?
Two magnets are positioned on opposite sides of a target tissue area. Over time, the magnets gently compress the tissue between them. The compressed tissue eventually opens, creating a connection (anastomosis) between two segments of bowel. The device is then passed naturally from the body once wound strength is adequate to maintain the anastomosis.
What the FDA authorized
The MagDI™ System by GT Metabolic received FDA De Novo marketing authorization for the creation of side-to-side duodeno-ileal anastomoses in minimally invasive and laparoscopic surgery. FDA documentation states that the effects of the device on weight loss were not studied.
- De Novo authorization: DEN240013 (July 2, 2024).
- 510(k) clearance for 40 mm magnet: K242086 (October 2024).
- 510(k) clearance for 50 mm magnet: K243359 (February 2025).
What the FDA did not authorize
FDA documentation explicitly states: "The effects of this device on weight loss were not studied."The MagDI™ System is authorized as a device for anastomosis creation. It is not authorized as a weight-loss treatment, an obesity treatment, or a diabetes treatment.
How MagnaMetabolic uses MagDI™
MagnaMetabolic surgeons may use the MagDI™ System within broader metabolic surgical pathways such as Sleeve Plus™ and Diabetes Magna Plus™. Whether MagDI™ is appropriate for any individual patient depends on a full clinical evaluation.