da Vinci 5 FDA clearance for select cardiac procedures
Key Questions
What recent FDA clearance did da Vinci 5 receive?
The FDA cleared da Vinci 5 for select cardiac procedures on March 17, 2026. This expands its use in cardiac surgeries, including potential for mitral repair.
How many da Vinci 5 placements occurred in Q4?
There were 303 da Vinci 5 placements in Q4, growing to a base of 1,232 units. This reflects strong initial adoption excluding certain models.
Which hospitals have introduced da Vinci 5 as regional firsts?
Regional firsts include St. Dominic, PIH Health, Northwell, Archbold, St. Agnes Fresno, and Kootenai Health in Idaho. Internationally, Epworth Freemasons in Australia and Clementine Churchill in the UK have also adopted it for various procedures.
What AI advancements are associated with da Vinci 5?
Intuitive Surgical is pushing AI integration, highlighted at NVIDIA GTC with Isaac GR00T and a foundation model for surgical robotics. Updates enable global surgeon collaboration via remote operations.
Who is Brian Miller and what is his new role?
Brian Miller, former EVP at Intuitive Surgical, has joined Sovato as CEO. Intuitive invested $26M in Sovato, with a 2025 transatlantic demo planned.
What new approvals has da Vinci 5 received internationally?
New EU and Japan approvals have been secured, supporting global rollout. This includes expansions in urology, gyn, thoracic, cardiac, and general surgery.
What is the market potential for lung cancer thoracic procedures?
The lung cancer thoracic TAM is $1.6B in 2026, growing to $2.8B by 2036 at 5.9% CAGR, providing a tailwind against competitors like Medtronic and Ethicon. Overall cardio TAM reaches $41.29B by 2032.
What key metrics are open for monitoring with da Vinci 5?
Key areas include U.S. placement cadence, training and ramp-up, reimbursement status, and revenue impact in the Q1 2026 report, which is a crucial test for the platform.
FDA cleared for cardiac (2026-03-17, Q4 303 placements to 1,232 base ex-1A7QZjJM, first Australia Epworth Freemasons ex-28e4822e urology/gyn/thoracic/cardiac/general, rollout UK Clementine Churchill [rexgCt], U.S. St. Dominic [2H6uI8]/PIH Health [7SCljG]/Northwell/Archbold/St. Agnes Fresno/Kootenai Health Idaho regional first ex-1AGmxcQ9/c31e9ddc/735eaf30/47c6f744/1AGlcV8a; mitral repair ex-a2abdbf6/NVIDIA GTC/Isaac GR00T/AI push ex-1A7Bougt/ex-1ADvmx11/2a14fd84/ca44e259; MALS release demo ex-97f06498; updates enabling global surgeon collaboration via remote ops ex-710411e0; ex-ISRG EVP Brian Miller to Sovato CEO (ISRG $26M investee, 2025 transatlantic demo ex-1AFRFCsX); new EU/Japan approvals ex-9f3f21b7/33d516ff bull). Lung cancer thoracic TAM $1.6B '26-$2.8B '36 5.9%CAGR tailwind vs Medtronic/Ethicon ex-5d875c9c/ex-fc3bfeeb. TAM ~160k; cardio $41.29B by 2032 ex-19rheH5X. Open: U.S. cadence, training/ramp, reimbursement, rev/Q1 test ex-15fbe704.