GALWAY, Ireland - Medtronic plc (NYSE:MDT) submitted 510(k) clearance applications to the U.S. Food and Drug Administration for its Hugo robotic-assisted surgery system to expand into general surgery and gynecologic procedures, according to a press release statement issued today.
The company also submitted a 510(k) filing for the LigaSure RAS Maryland instrument for use with the Hugo system and received 510(k) clearance for ProGrip Advanced self-gripping polypropylene mesh for robotic-assisted ventral hernia repair surgeries.
The Hugo RAS system received FDA clearance for urologic surgical procedures in December 2025 and is currently in commercial use at U.S. medical centers. The system has been used commercially for nearly five years across more than 35 countries.The expansion comes as Medtronic, with a market capitalization of $94.7 billion, trades near its 52-week low at $73.75. According to InvestingPro analysis, the stock appears undervalued at current levels, presenting a potential opportunity for investors. The company generated $35.5 billion in revenue over the last twelve months with 6.9% growth, demonstrating solid momentum in its healthcare equipment business. InvestingPro subscribers can access the company’s Fair Value estimate and explore other undervalued opportunities on the platform’s Most Undervalued stocks list.
Medtronic completed enrollment in the Embrace Gynecology Investigational Device Exemption clinical study for the Hugo system. The prospective multicenter study enrolled 70 patients across five U.S. hospitals to evaluate the safety and effectiveness of the system in robotic-assisted gynecologic procedures.
The LigaSure RAS Maryland instrument is designed for use with the Valleylab FT10 energy platform on the Hugo system. LigaSure vessel-sealing technology has been used in more than 35 million procedures across 65 countries, according to the company.
ProGrip Advanced mesh represents an evolution of existing mesh technologies for robotic-assisted ventral hernia repair. ProGrip meshes have been used in more than 6 million procedures. The company stated that approximately 470,000 ventral hernia repair procedures are performed annually in the U.S.Medtronic’s financial stability is underscored by its remarkable 50-year streak of consecutive dividend payments, with a current yield of 3.85%. For deeper insights into Medtronic’s strategic positioning and growth prospects, investors can access the comprehensive Pro Research Report, available for MDT and 1,400+ other US equities on InvestingPro.
"These milestones and innovative technologies will unlock our ability to enhance the value of our partnership in general and gynecologic surgical procedures," said Matt Anderson, senior vice president and president of the Surgical business at Medtronic.
The company is headquartered in Galway, Ireland, and employs more than 95,000 people across more than 150 countries.
In other recent news, Medtronic plc has announced its intent to acquire SPR Therapeutics, Inc. for approximately $650 million in cash. This acquisition will expand Medtronic’s portfolio by adding SPR’s SPRINT Peripheral Nerve Stimulation System, which offers a 60-day therapy for chronic pain management without requiring a permanent implant. Additionally, Medtronic has made strategic investments in two companies developing intracardiac echocardiography catheter technologies, Beluga Medical and CardioACC. CardioACC, based in Shenzhen, China, has received approval from the National Medical Products Administration for its ICE system, which is significant for Medtronic’s expansion in this area.
Furthermore, Goldman Sachs has reinstated its coverage of Medtronic stock with a Neutral rating and set a price target of $84.00, indicating a potential upside of approximately 7.5% from recent market levels. Investors are also anticipating Medtronic’s earnings release on June 3, with options data suggesting a potential stock movement of 4.1%. These developments highlight Medtronic’s ongoing efforts to enhance its product offerings and maintain its position in the medical technology sector.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.
Most traders can read a chart. The hard part is the moment: entry window open, pattern forming, and you're still waiting for more confirmation. That's the conviction gap — and our chart analysis closes it. Unlike other AIs that just read data, our Vision AI literally "sees" your charts and hands you a complete trading plan: entry, stop-loss, and profit target in under 60 seconds. Know exactly what to do next, every time.