Question 1

Is MagDI FDA approved?

Accepted Answer

The first-generation MagDI System received FDA De Novo Marketing Authorization (DEN240013) on July 2, 2024. The second-generation MagDI System received FDA 510(k) clearance (K242086) on October 24, 2024. A larger 50 mm magnet was cleared in 2025 (K243359). 'FDA approval' is a specific regulatory term most commonly associated with the Premarket Approval (PMA) pathway; MagDI's regulatory status to date is more precisely described as 'authorized' (De Novo) and 'cleared' (510(k)).

Question 2

What is FDA De Novo authorization?

Accepted Answer

De Novo is a U.S. FDA pathway for novel devices of low-to-moderate risk that do not have a legally marketed predicate. A De Novo authorization establishes a new device classification and special controls. MagDI received De Novo authorization in July 2024 under DEN240013.

Question 3

What is the difference between FDA authorization and FDA clearance?

Accepted Answer

Authorization typically refers to a De Novo grant for novel devices that establish a new classification. Clearance typically refers to a 510(k), where a device is found substantially equivalent to a legally marketed predicate. Neither is the same as Premarket Approval (PMA), the most rigorous pathway used for certain Class III devices.

Question 4

Is MagDI reversible?

Accepted Answer

MagDI creates a side-to-side anastomosis (a new connection) between the duodenum and the ileum. The original anatomy is not removed. Whether and how an anastomosis can be revised or addressed depends on each patient's anatomy and clinical situation; this should be discussed with a qualified bariatric and metabolic surgeon.

Question 5

Does MagDI use staples?

Accepted Answer

The anastomosis itself is formed by magnetic compression of the tissue between two self-aligning magnets, not by staples at the anastomosis site. Other portions of a combined procedure (for example, the sleeve gastrectomy component of Sleeve Plus) may still use staples.

Question 6

Does MagDI use sutures?

Accepted Answer

The duodeno-ileal anastomosis formed by the MagDI magnets does not rely on sutures at the magnet site. Surgical sutures may still be used elsewhere during the overall operation.

Question 7

Are magnets left in the body permanently?

Accepted Answer

No. The magnets are designed to fuse together and detach as a single unit once the anastomosis matures, then pass naturally through the gastrointestinal tract. No permanent foreign material remains at the anastomosis site.

Question 8

What clinical studies have been published?

Accepted Answer

Published human experience includes a first-in-human study (Obesity Surgery), a multi-center early outcomes study of Sleeve Plus MagDI (Surgical Endoscopy), and a revisional study of MagDI after prior sleeve gastrectomy (Surgery for Obesity and Related Diseases). See the Clinical Studies page for summaries.

Question 9

How much weight loss has been reported?

Accepted Answer

Published Sleeve Plus MagDI studies report meaningful short- and mid-term weight loss, with specific percentages varying by study, follow-up duration, and baseline BMI. Results vary among individuals; long-term durability is still being evaluated.

Question 10

Can MagDI improve diabetes?

Accepted Answer

Published studies report improvements in glycemic control and, in some patients, diabetes remission as defined within each study. Outcomes depend on baseline disease severity, duration of diabetes, beta-cell reserve, and adherence to follow-up. Diabetes remission is not equivalent to a cure and may not be sustained in all patients.

Question 11

Who is not a candidate?

Accepted Answer

Candidacy is determined by a qualified bariatric and metabolic surgery team based on medical history, prior surgeries, anatomy, comorbid conditions, and clinical trial criteria where applicable. See the Contraindications page for general categories.

Question 12

What are the known risks?

Accepted Answer

Reported risks include bleeding, infection, bowel obstruction, anastomotic stricture, nutritional deficiencies, reoperation, and failure to achieve expected outcomes, along with the standard risks of anesthesia and abdominal surgery. See the Safety & Risks page for detail.

Frequently Asked Scientific Questions

Scientific References