WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Exit Postmarket & security

THE TAPE

Apollo is in talks to buy J&J's DePuy Synthes for close to $20B BRAINBox signs Prolight to supply the readers for its concussion blood test Intuitive wins a CE mark for transvaginal surgery with the da Vinci SP Beta Bionics clears the Mint patch pump and cuts 2026 guidance the same day J&J sells the Laminar LAA program it bought for $400M upfront in 2023 GE HealthCare is in talks to buy Sofie Biosciences for about $1B Implicity raises $40M to run cardiac implant monitoring across four vendors Boston Scientific says plants and shipping are fully back 17 days after the cyberattack FDA seeks comment on device tracking and raises the burden estimate by 47,526 hours Apollo is in talks to buy J&J's DePuy Synthes for close to $20B BRAINBox signs Prolight to supply the readers for its concussion blood test Intuitive wins a CE mark for transvaginal surgery with the da Vinci SP Beta Bionics clears the Mint patch pump and cuts 2026 guidance the same day J&J sells the Laminar LAA program it bought for $400M upfront in 2023 GE HealthCare is in talks to buy Sofie Biosciences for about $1B Implicity raises $40M to run cardiac implant monitoring across four vendors Boston Scientific says plants and shipping are fully back 17 days after the cyberattack FDA seeks comment on device tracking and raises the burden estimate by 47,526 hours

CE mark

Intuitive wins a CE mark for transvaginal surgery with the da Vinci SP

MedDevice Startups Staff · 1 day ago · 2 min read · Via Intuitive release

Intuitive has a CE mark for transvaginal gynecologic procedures with the da Vinci SP system, announced September 14. The company calls the indication a first for the platform.

SP already carried CE marks for endoscopic abdominopelvic, thoracoscopic, transoral otolaryngology, transanal colorectal and breast procedures. It is approved in the US, Japan and Korea as well. The system drives up to three articulating instruments and a 3D endoscope through one port. Dirk Barten, Intuitive's commercial president for Europe, framed the approval as widening access to less invasive options for women.

The release gave no availability date for European hospitals. For anyone building single-port or natural-orifice instruments, the useful detail is the access route. A notified body accepted transvaginal access on a platform originally marked for abdominopelvic work, which is a shorter argument than starting from nothing.

Questions & Answers

What did Intuitive's da Vinci SP CE mark cover in September 2026?

Intuitive announced on September 14, 2026 that the da Vinci SP system received a CE mark for transvaginal gynecologic procedures in Europe, which the company describes as a first for the platform.

What procedures was the da Vinci SP already CE marked for?

Before the transvaginal indication, the da Vinci SP held CE marks for endoscopic abdominopelvic, thoracoscopic, transoral otolaryngology, transanal colorectal and breast procedures. It is also approved in the US, Japan and Korea.

← Back to Newly Cleared