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ISRG Gets FDA Clearance to Use da Vinci SP Robot for General Surgeries
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Key Takeaways
ISRG gained FDA clearance to use its da Vinci SP system for hernia repair, cholecystectomy and appendectomy.
The approval expands SP's general surgery use and supports less invasive procedures with faster recovery.
SP platform enhancements and rising minimally invasive cases drove 91% SP procedure growth in Q3.
Intuitive Surgical (ISRG - Free Report) recently announced that it has received FDA clearance to expand the use of the da Vinci Single Port (SP) robotic system for three new types of surgeries — inguinal hernia repair, cholecystectomy and appendectomy surgeries. This approval considerably broadens da Vinci SP’s usage across general surgery and adds to its existing U.S. clearances for surgeries in areas like the urinary system, colon and rectum, chest and mouth/throat.
Management highlighted that single-port methods will support less invasive surgeries, leading to reduced trauma, faster recovery, low-cost procedures and better patient experience. With more than 500 peer-assessed studies proving the safety and effectiveness of the da Vinci SP robot system for a variety of surgeries in Europe, Japan and Korea, ISRG focuses on fulfilling its long-term commitment to advance the future of minimally invasive care with new tools and capabilities.
Likely Trend of ISRG Stock Following the News
Following the announcement, the company's shares declined 0.4% at yesterday’s close. Year to date, shares of Intuitive Surgical have gained 6.5% compared with the industry’s 3.2% growth and the S&P 500’s 19.5% rise.
Image Source: Zacks Investment Research
In the long run, the da Vinci SP surgical method is likely to broaden ISRG’s competitive position in minimally invasive surgery by anchoring its robotically guided technology directly to three of the most common surgery procedures in the United States — inguinal hernia repair, gallbladder removal and appendix removal. The FDA clearance gives the company a clear pathway to promote its single-port robots, boosting demand among patients seeking less invasive procedures and faster recovery. Collectively, these factors amplify ISRG’s presence in the minimally invasive surgery market and improve its long-term growth trajectory.
ISRG currently has a market capitalization of $200.08 billion.
More on the Expanded SP Indications
The da Vinci SP system operates through a single incision or natural opening using up to three flexible multi-jointed instruments along with a 3D high-definition camera to give a clear view inside the body, providing surgeons with precise dissection and controlled access to work in deep anatomical areas more easily and safely.
ISRG explained that improving the da Vinci SP system with modern capabilities is a key step in the ongoing evolution of the SP platform to make patient care better. Their focus is on developing new technologies across all surgical methods that are less invasive, while maintaining their age-old priority to help patients recover faster, lower overall healthcare costs and make minimally invasive surgeries more comfortable for people.
As minimally invasive surgery cases continue to rise, the successive evolution of single-port robot-assisted invasive surgical systems with new tools, software enhancements and workflow integration deepens customer adoption and positions ISRG to seize long-term growth in minimally invasive care while utilizing its technology across different types of invasive surgeries around the world. This is evident from the fact that SP platform procedures surged 91% during the third quarter.
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ISRG Gets FDA Clearance to Use da Vinci SP Robot for General Surgeries
Key Takeaways
Intuitive Surgical (ISRG - Free Report) recently announced that it has received FDA clearance to expand the use of the da Vinci Single Port (SP) robotic system for three new types of surgeries — inguinal hernia repair, cholecystectomy and appendectomy surgeries. This approval considerably broadens da Vinci SP’s usage across general surgery and adds to its existing U.S. clearances for surgeries in areas like the urinary system, colon and rectum, chest and mouth/throat.
Management highlighted that single-port methods will support less invasive surgeries, leading to reduced trauma, faster recovery, low-cost procedures and better patient experience. With more than 500 peer-assessed studies proving the safety and effectiveness of the da Vinci SP robot system for a variety of surgeries in Europe, Japan and Korea, ISRG focuses on fulfilling its long-term commitment to advance the future of minimally invasive care with new tools and capabilities.
Likely Trend of ISRG Stock Following the News
Following the announcement, the company's shares declined 0.4% at yesterday’s close. Year to date, shares of Intuitive Surgical have gained 6.5% compared with the industry’s 3.2% growth and the S&P 500’s 19.5% rise.
Image Source: Zacks Investment Research
In the long run, the da Vinci SP surgical method is likely to broaden ISRG’s competitive position in minimally invasive surgery by anchoring its robotically guided technology directly to three of the most common surgery procedures in the United States — inguinal hernia repair, gallbladder removal and appendix removal. The FDA clearance gives the company a clear pathway to promote its single-port robots, boosting demand among patients seeking less invasive procedures and faster recovery. Collectively, these factors amplify ISRG’s presence in the minimally invasive surgery market and improve its long-term growth trajectory.
ISRG currently has a market capitalization of $200.08 billion.
More on the Expanded SP Indications
The da Vinci SP system operates through a single incision or natural opening using up to three flexible multi-jointed instruments along with a 3D high-definition camera to give a clear view inside the body, providing surgeons with precise dissection and controlled access to work in deep anatomical areas more easily and safely.
ISRG explained that improving the da Vinci SP system with modern capabilities is a key step in the ongoing evolution of the SP platform to make patient care better. Their focus is on developing new technologies across all surgical methods that are less invasive, while maintaining their age-old priority to help patients recover faster, lower overall healthcare costs and make minimally invasive surgeries more comfortable for people.
As minimally invasive surgery cases continue to rise, the successive evolution of single-port robot-assisted invasive surgical systems with new tools, software enhancements and workflow integration deepens customer adoption and positions ISRG to seize long-term growth in minimally invasive care while utilizing its technology across different types of invasive surgeries around the world. This is evident from the fact that SP platform procedures surged 91% during the third quarter.
Intuitive Surgical, Inc. Price
Intuitive Surgical, Inc. price | Intuitive Surgical, Inc. Quote
ISRG’s Zacks Rank & Other Key Picks
Currently, ISRG flaunts a Zacks Rank #1 (Strong Buy).
Some other top-ranked stocks from the broader medical space are Veracyte (VCYT - Free Report) , Artivion (AORT - Free Report) and EDAP TMS (EDAP - Free Report) .
Veracyte, sporting a Zacks Rank #1 at present, reported third-quarter 2025 adjusted earnings per share (EPS) of 51 cents, which surpassed the Zacks Consensus Estimate by 59.38%. 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 growth rate of 38.7% for 2025 compared with the industry’s 13.1% rise. The company beat earnings estimates in the trailing four quarters, the average surprise being 45.12%.
Artivion, currently carrying a Zacks Rank #2 (Buy), reported a third-quarter 2025 adjusted EPS of 16 cents, which surpassed the Zacks Consensus Estimate by 14.3%. Revenues of $113.3 million beat the Zacks Consensus Estimate by 1.8%.
AORT has an estimated earnings growth rate of 140% for 2025 compared with the industry’s 13.1% rise. The company delivered a negative average earnings surprise of 4.38% in the trailing four quarters.
EDAP TMS, currently carrying a Zacks Rank #2, reported a third-quarter 2025 loss per share of 15 cents, narrower than the Zacks Consensus Estimate by 42.31%. Revenues of $16.1 million topped the Zacks Consensus Estimate by 7.1%.
EDAP’s loss per share for 2025 is projected to widen 25.5%, while the industry’s earnings are expected to grow 13.1%. The company’s earnings beat estimates in each of the trailing four quarters, the average surprise being 19.36%.