ISRG · 10-Q · 2026Q2 · Full report

Regulatory Approval Milestones

INTUITIVE SURGICAL INC · 2026-07-21 · Importance 41 · Surprise 60

During 2026, Intuitive received China’s NMPA approval for the E-200 energy generator, FDA clearance for extended-use da Vinci 5 force-feedback instruments, and FDA clearance for selected thoracoscopically assisted cardiac procedures using da Vinci 5. In Japan, seven additional da Vinci procedures, including inguinal hernia repair, received reimbursement effective June 2026, and hospitals exceeding 200 qualifying robotic procedures per year became eligible for incremental reimbursement. The company continues pursuing broader indications and geographic clearances for da Vinci 5, da Vinci SP, and Ion. Adoption of newly reimbursed Japanese procedures may be slower than prostatectomy and partial nephrectomy because several have reimbursement levels comparable to conventional laparoscopy.

Key facts

• In April 2026, we obtained NMPA regulatory approval for our E-200 generator in China; in December 2024, we obtained European certification in accordance with the EU MDR for the same generator. source
• In March 2026, we obtained FDA clearance for updates to our force feedback instruments used with our da Vinci 5 surgical system, including approval for extended instrument lives: five of the six force feedback instruments were cleared for up to 15 uses, while the remaining instrument was cleared for up to 10 uses. source
• In January 2026, we obtained FDA clearance for the use of our da Vinci 5 surgical system in selected thoracoscopically-assisted cardiac surgical procedures using non-force feedback instruments (list of procedures included). source
• In September 2025, we obtained regulatory clearance in Japan for our Vessel Sealer Curved; in June 2025, we obtained FDA clearance for the same instrument. source
• In July 2025, we obtained European certification in accordance with the EU MDR for our da Vinci 5 surgical system for adult and pediatric use in minimally invasive endoscopic procedures across abdominopelvic and thoracoscopic surgical procedures, excluding the use of force feedback. source
• In March 2024, we obtained FDA clearance for our da Vinci 5 surgical system for use in all surgical specialties and procedures indicated for da Vinci Xi, except for cardiac and pediatric indications as well as one contraindication related to the use of force feedback in hysterectomy and myomectomy procedures. source
• The da Vinci SP surgical system received European certification in January 2024 in accordance with the EU MDR for use in endoscopic abdominopelvic, thoracoscopic, transoral otolaryngology, transanal colorectal, and breast surgical procedures. source
• In August 2024, we obtained regulatory clearance in Taiwan for our da Vinci SP surgical system for use in endoscopic abdominopelvic, thoracoscopic, transoral otolaryngology, transanal colorectal, transanal total mesorectal excision, and breast surgical procedures. source