Regulator
The FDA cleared Symani through the De Novo route (DEN230032) for microsurgery on soft tissue.
A regulator's decision · Sets Symani's stage
What the source says
“Medical Microinstruments announced today that the FDA granted de novo clearance for its Symani surgical robot platform.”
What it means
Symani, from MMI (Medical Microinstruments), is at stage 5 of 5 on our ladder: regulator-cleared or mass market. This event is one of the milestones that placed it there.
Human help: Our sources report it working without human help.
More on Symani
- Baptist Health in Jacksonville, Florida did the first operation in a US study (REMIND) testing Symani microsurgery for Alzheimer's and similar brain diseases. The study plans 15 patients.
- A new US billing code for lymph-to-vein bypass surgery with robot help (CPT 1019T) was created, taking effect 1 January 2026, so hospitals can bill for these operations.
- Penn Presbyterian Medical Center did the first two US operations with Symani, rebuilding damaged limbs.
- MMI said surgeons had used Symani in nearly 1,000 operations in Europe before the US clearance.