FDA & Regulatory Status
FDA Status of MagDI Technology
The MagDI System for magnetic duodeno-ileostomy has progressed through multiple U.S. FDA regulatory pathways. This page summarizes the verifiable milestones and links directly to the FDA databases where each authorization can be independently confirmed.
The information below is drawn from publicly accessible FDA databases. Inclusion on this page does not imply endorsement by the U.S. Food and Drug Administration. Patients considering any procedure should discuss regulatory status, device specifics, and individual candidacy with their surgical team.
MagDI™ System — Precise FDA Language
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 granted July 2, 2024 (DEN240013). The second-generation MagDI™ System with the 40 mm DI Magnet and 50 mm DI Magnet received U.S. FDA 510(k) clearances in October 2024 and February 2025 respectively, identified by GT Metabolic as K242086 and K243359.
Precise FDA indication (as authorized)
The GT Metabolic MagDI System is intended for use in the creation of side-to-side duodeno-ileal anastomoses in minimally invasive and laparoscopic surgery. Once wound strength is sufficient to maintain the anastomosis, the device is passed from the body.
Important FDA limitation on weight-loss claims
FDA De Novo documentation states: “The effects of this device on weight loss were not studied.”
For this reason, MagnaMetabolic does not describe MagDI™ as an FDA-approved weight-loss or diabetes treatment. Use in metabolic and bariatric surgery pathways should be discussed with qualified healthcare professionals.
Regulatory milestones
The first-generation MagDI System received U.S. FDA De Novo Marketing Authorization on July 2, 2024. De Novo authorization is granted for novel devices of low-to-moderate risk that do not have a legally marketed predicate. This authorization establishes a new device classification and special controls for magnetic duodeno-ileostomy.
Source: FDA De Novo Classification Database →The second-generation MagDI System received U.S. FDA 510(k) clearance on October 24, 2024. A 510(k) is a premarket submission demonstrating substantial equivalence to a legally marketed device — in this case, the first-generation MagDI System authorized under DEN240013.
Source: FDA 510(k) Database →An additional 510(k) clearance for the larger 50 mm MagDI magnet was granted in 2025, expanding the available configurations of the MagDI System.
Source: FDA 510(k) Database →How to read FDA authorizations
- De Novo authorization is for novel devices that do not have a legally marketed predicate; it creates a new device classification with special controls.
- 510(k) clearance demonstrates that a device is substantially equivalent to a legally marketed predicate device.
- Neither pathway is the same as FDA Premarket Approval (PMA), which is the most rigorous pathway and applies to certain Class III devices.
- FDA authorization or clearance is not a guarantee of clinical outcomes for any individual patient.