ISRG's da Vinci Gets FDA Nod for Advanced Cardiac Procedures

Intuitive Surgical ISRG recently announced that the FDA has granted 510(k) clearance for the da Vinci 5 system to be used in certain cardiac procedures, including mitral valve repair and internal mammary artery (IMA) mobilization for cardiac revascularization. The company has formed a cardiac-focused team to build infrastructure, customized training programs, clinical evidence development and the design of cardiac-specific instruments. It expects a limited number of United States centers to collaborate through 2026 to establish initial da Vinci 5 cardiac programs.Per management, traditional open-chest cardiac surgery is associated with significant pain, risk and prolonged recovery, impacting patient outcomes. The FDA clearance underscores the company’s focus on expanding minimally invasive cardiac surgery to improve clinical outcomes. The da Vinci 5 platform represents the launch of a broader global cardiac care strategy, leveraging decades of innovation, standardized team-based training and a reliable service model to support scalable and sustainable adoption of robotic-assisted cardiac surgery.Likely Trend of ISRG Stock Following the NewsFollowing the announcement, shares of ISRG gained 0.9% at yesterday’s closing. Over the past six months, shares of the company have climbed 7.1% compared with the industry’s 5% growth and the S&P 500’s 10.9% rise.In the long run, Intuitive Surgical strengthens its growth narrative by re-entering a large procedural category where penetration of robotic-assisted minimally invasive surgery remains low. The clearance validates the technological advancements of da Vinci 5, including enhanced computing power, smart instrumentation and advanced imaging, reinforcing the company’s innovation edge. With cardiovascular disease remaining the leading global cause of death and millions of surgeries performed annually, this expansion enlarges ISRG’s addressable market. Overall, the announcement underscores the company’s strategic execution, deepens its competitive moat and supports sustained growth across global healthcare systems.ISRG currently has a market capitalization of $187.84 billion.Image Source: Zacks Investment ResearchMore on the da Vinci 5 SystemCardiac surgery was the first specialty approved for the original da Vinci System in 2002, and more than 140,000 robotic-assisted cardiac procedures have been performed in 51 countries. Although early results showed promise, the technical constraints of early systems and limited global training led Intuitive Surgical to redirect its focus. With these challenges now resolved, da Vinci 5 enables renewed growth in minimally invasive cardiac surgery.The da Vinci 5 is designed to enable minimally invasive cardiac surgery by allowing surgeons to work through small incisions without splitting the breastbone. The system features 10,000-times greater computing power to drive future innovation, smart instruments that capture over 1,000 data points per second and advanced imaging to improve visualization of vessels and perfusion. These capabilities are integrated into a digital ecosystem that supports the entire surgical journey — from pre-operative planning to post-operative analysis.The da Vinci 5 is currently indicated for a defined set of thoracoscopically assisted cardiac procedures performed with non-force feedback instruments. These include mitral valve repair and replacement, tricuspid valve repair, internal mammary artery mobilization for coronary revascularization, closure of patent foramen ovale and atrial septal defects, left atrial appendage closure or occlusion, excision of atrial myxomas and placement of epicardial pacing leads. These indications reflect the system’s expanding role in minimally invasive cardiac surgery and its potential to support broader procedural adoption over time.Industry Prospects Favoring the MarketGoing by data provided by Precedence Research, the minimally invasive medical robots market is anticipated to be valued at $66.10 billion in 2026 and is expected to witness a CAGR of 13.6% through 2035. Factors like increased demand for minimally invasive surgeries, robotic technological breakthroughs, healthcare investment upsurge and favorable regulatory concessions are driving the market’s growth.Other NewsIntuitive Surgical announced that it has received FDA clearance to expand the use of the da Vinci Single Port (SP) robotic system for inguinal hernia repair, cholecystectomy and appendectomy surgeries. This approval broadens da Vinci SP’s usage across general surgery, building on its existing U.S. clearances for surgeries in areas like the urinary system, colon and rectum, chest and mouth/throat.Intuitive Surgical, Inc. Price Intuitive Surgical, Inc. price | Intuitive Surgical, Inc. QuoteISRG’s Zacks Rank & Key PicksCurrently, ISRG carries a Zacks Rank #3 (Hold).Some top-ranked stocks from the broader medical space are Veracyte VCYT, AtriCure ATRC and Boston Scientific BSX.Veracyte, sporting a Zacks Rank #1 (Strong Buy) at present, reported third-quarter 2025 adjusted earnings per share (EPS) of 51 cents, which surpassed the Zacks Consensus Estimate by 59.4%. Revenues of $131.8 million beat the Zacks Consensus Estimate by 5.5%. You can see the complete list of today’s Zacks #1 Rank stocks here.VCYT has an estimated earnings recession rate of 3% for 2026 compared with the industry’s 17.7% rise. The company beat earnings estimates in the trailing four quarters, the average surprise being 45.1%.AtriCure, currently sporting a Zacks Rank #1, reported a third-quarter 2025 adjusted loss of 1 cent per share, narrower than the Zacks Consensus Estimate by 90.9%. Revenues of $134.3 million beat the Zacks Consensus Estimate by 2.1%.ATRC has an estimated earnings growth rate of 91.7% for 2026 compared with the industry’s 17.7% rise. The company beat earnings estimates in the trailing four quarters, the average surprise being 67.1%.Boston Scientific, currently carrying a Zacks Rank #2 (Buy), reported a third-quarter 2025 adjusted EPS of 75 cents, which surpassed the Zacks Consensus Estimate by 5.6%. Revenues of $5.07 billion beat the Zacks Consensus Estimate by 1.9%.BSX has an estimated long-term earnings growth rate of 16.4% compared with the industry’s 13.1% growth. The company’s earnings beat estimates in each of the trailing four quarters, the average surprise being 7.4%.Just Released: Zacks Top 10 Stocks for 2026Hurry – you can still get in early on our 10 top tickers for 2026. 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(VCYT): Free Stock Analysis ReportThis article originally published on Zacks Investment Research (zacks.com).Zacks Investment ResearchWeiter zum vollständigen Artikel bei Zacks Weiter zum vollständigen Artikel bei Zacks