Devices and Diagnostics

Intuitive Surgical was founded in 1995 to commercialise robotic telesurgery technology licensed from SRI International, research originally aimed at operating on soldiers remotely. The military use never became a business; the surgeon's console did. The da Vinci robot cost roughly $1 million or more, needed instruments replaced after a set number of uses and had to justify its price. The turning point was one operation. After the FDA cleared da Vinci for radical prostatectomy in 2001, urologists adopted it rapidly, before randomised evidence existed; gynaecology followed from 2005, and general surgery later. A 2016 randomised trial in The Lancet found similar functional outcomes at 12 weeks for robotic and open prostatectomy, which critics cited against the robot's premium and supporters dismissed for its single-surgeon design.

By 2025 Intuitive reported about $10.06 billion of revenue (up about 21%), about 3.15 million da Vinci procedures and an installed base of 11,106 systems (company 10-K). Systems sales were about $2.47 billion, so roughly three-quarters of revenue came from instruments, accessories and service consumed with every case. Its record also includes an FDA warning letter in 2013, product-liability suits and a stall in 2014, and antitrust suits over its limits on instrument reuse: a January 2025 ruling for Intuitive against the refurbisher SIS was reversed on SIS's appeal by the Ninth Circuit on 13 August 2026, which sent the case back to the district court, and a $450 million charge in the third quarter of 2026 settled a hospital class action, subject to court approval. Intuitive shows the most valuable device model and the evidence and conduct questions that come with it.