Dive Brief:
- Medtronic has filed for Food and Drug Administration approval of its Hugo soft tissue robotic surgery system with a urologic indication, marking a major step in its bid to compete with Intuitive Surgical. The company said Saturday that it made the submission in the first quarter of 2025.
- Medtronic also completed enrollment in hernia and benign gynecology studies and received approval to start a trial in oncologic gynecology procedures. The studies will support submissions for additional U.S. indications for the robot.
- Data from the company’s investigational device exemption study for the Hugo robot in urologic surgery, presented at the American Urological Association annual meeting, met the primary goals for safety and effectiveness, according to Medtronic.
Dive Insight:
Medtronic’s Hugo system is used in more than 25 countries, but in the U.S. – the world’s largest robotic surgery market – Intuitive has a head start of more than two decades. Medtronic first unveiled its robotic program to investors in 2019, William Blair analyst Brandon Vazquez noted Monday in a report to investors.
The FDA submission puts Medtronic on track for approval in urological procedures in the second half of this year, said Vazquez.
“While we are believers that Intuitive’s technology remains well ahead of the competition,” Vazquez wrote, “2025 is shaping up to be the first year with meaningful U.S. market entrants like Medtronic and even private players like CMR Surgical.”
Vazquez said that while Medtronic’s market entry does not “meaningfully” change Intuitive’s growth outlook, the new competition could lengthen selling cycles.
Furthermore, the analyst said, “physicians often prefer to have options in medicine, which will likely give some support to competitive adoption in the coming years.”
Completion of enrollment in the hysterectomy and hernia trials suggests indication expansions are moving along, which will be key for Hugo, he added, noting that Medtronic’s urologic study data for the robot was positive, showing high surgical success rates and complication rates in line or better than those published for other robotic platforms.
Medtronic said the study's 98.5% surgical success rate exceeded the performance goal of 85%.
On the company’s fiscal third-quarter call in February, CEO Geoff Martha predicted Hugo would contribute to growth in Medtronic’s surgical business in fiscal 2026 and be a “meaningful growth driver” for the company over the medium term.
Medtronic will report its latest earnings results on Wednesday, May 21.
