This section highlights FDA-related milestones and regulatory updates for drugs developed by Medtronic (MDT).
Over the past two years, Medtronic has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Hugo, MiniMed™, MiniMed, BrainSense, InPen, PulseSelect, and Affera™. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
Hugo FDA Regulatory Timeline and Events
Hugo is a drug developed by Medtronic for the following indication: for gynecological procedures.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Hugo
- Announced Date:
- February 17, 2026
- Indication:
- for gynecological procedures
Announcement
Medtronic announced that the first U.S. commercial surgical case using its recently FDA-cleared Hugo™ robotic-assisted surgery (RAS) system has been successfully performed by Jihad Kaouk, MD, professor and chair of the Glickman Urologic Institute and the Zegarac-Pollock Endowed Chair in Robotic Surgery at Cleveland Clinic.
AI Summary
Medtronic announced that the first U.S. commercial surgical case using its recently FDA-cleared Hugo™ robotic-assisted surgery (RAS) system has been successfully performed by Jihad Kaouk, MD. Dr. Kaouk is professor and chair of the Glickman Urologic Institute and holds the Zegarac-Pollock Endowed Chair in Robotic Surgery at Cleveland Clinic. The company said the case was completed this month, marking the start of Hugo’s commercial use in the United States.
Medtronic described the milestone as a step toward offering hospitals and surgeons a new robotic option for minimally invasive procedures. The successful initial case is intended to support broader adoption and continued real-world evaluation of the system as it becomes available to more surgical teams and patients across the U.S.
Read Announcement- Drug:
- Hugo
- Announced Date:
- December 3, 2025
- Indication:
- for gynecological procedures
Announcement
Medtronic announced the U.S. Food and Drug Administration (FDA) has cleared the Hugo™ robotic-assisted surgery (RAS) system for use in urologic surgical procedures.
AI Summary
Medtronic announced the U.S. Food and Drug Administration (FDA) cleared the Hugo™ robotic-assisted surgery (RAS) system for urologic surgical procedures. The clearance brings a new robotic platform to U.S. hospitals, giving surgeons and patients more choice and helping expand access to minimally invasive care.
The Hugo RAS system uses a modular design so robotic arms can be moved, shared, and positioned to fit different operating rooms and patient needs. Its open surgeon console aims to improve awareness, reduce physical strain, and support team training. Hugo connects with Medtronic’s Touch Surgery digital tools for pre‑op training, remote proctoring, and AI‑driven post‑op case insights, letting teams review surgery videos soon after procedures.
Hugo is indicated for prostatectomy, nephrectomy, and cystectomy. The large Expand URO study showed it met key safety and effectiveness goals, and the system has been used widely around the world. Medtronic plans to extend Hugo to more specialties and integrate it into a connected operating room.
Read Announcement- Drug:
- Hugo
- Announced Date:
- October 8, 2025
- Indication:
- for gynecological procedures
Announcement
Medtronic plc announced the start of the Embrace Gynecology investigational device exemption (IDE) U.S. clinical study to evaluate the safety and effectiveness of its Hugo™ robotic-assisted surgery (RAS) system in robotic-assisted gynecological procedures.
AI Summary
Medtronic plc announced the start of the Embrace Gynecology investigational device exemption (IDE) U.S. clinical study to evaluate the safety and effectiveness of its Hugo™ robotic-assisted surgery (RAS) system in gynecological procedures. The first total hysterectomies were successfully completed at AHN West Penn Hospital in Pittsburgh by Dr. Sarah Crafton and Dr. Eirwen Miller.
Embrace Gynecology is a prospective, multicenter study set to enroll up to 70 patients across five U.S. hospitals. It will assess the Hugo RAS system during radical, modified radical, and total hysterectomies, including those for cancer. Robotic-assisted surgery aims to reduce complications, shorten hospital stays, and help patients return faster to their normal lives compared to open surgery.
“Women facing a gynecologic diagnosis want effective treatment and to get back to their full lives as quickly as possible,” said Dr. Emma Rossi, the study’s national principal investigator. Dr. James Porter, Medtronic’s chief medical officer for Robotic Surgical Technologies, noted that the Embrace study underscores the company’s commitment to expanding less invasive options for women in the U.S.
Read Announcement
MiniMed™ 780G FDA Regulatory Timeline and Events
MiniMed™ 780G is a drug developed by Medtronic for the following indication: For people with type 1 diabetes.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- MiniMed™ 780G
- Announced Date:
- February 2, 2026
- Indication:
- For people with type 1 diabetes
Announcement
Medtronic announced three significant U.S. milestones that expand access, choice, and flexibility for people living with type 1 and insulin‑requiring type 2 diabetes.
AI Summary
Medtronic announced three U.S. milestones that expand access, choice, and flexibility for people with type 1 and insulin‑requiring type 2 diabetes by broadening options for its MiniMed™ 780G automated insulin delivery system. The company now supports the Abbott Instinct continuous glucose monitor (CGM), offers additional insulin options including faster‑acting insulins, and has put in place a Medicare billing and fulfillment pathway so eligible customers who ordered with the Instinct sensor can move forward through standard processes.
The Instinct sensor is slim, discreet, and can be worn up to 15 days, increasing wear time and convenience. Medtronic is also working with distributors to help ensure readiness and timely shipment for eligible users.
These changes aim to make automated insulin delivery easier to use—adjusting insulin every five minutes, reducing highs and lows, cutting daily decision‑making, and giving people more flexibility and confidence in managing diabetes.
Read Announcement- Drug:
- MiniMed™ 780G
- Announced Date:
- September 2, 2025
- Indication:
- For people with type 1 diabetes
Announcement
Medtronic plc announced two U.S. Food and Drug Administration (FDA) regulatory milestones that broaden the MiniMed™ 780G system portfolio: clearance of the SmartGuard™ algorithm as an interoperable automated glycemic controller (iAGC), enabling integration with the Instinct sensor, made by Abbott, for type 1 diabetes, and approval of the MiniMed™ 780G system for use in adults 18+ with insulin-requiring type 2 diabetes.
AI Summary
Medtronic announced two new U.S. Food and Drug Administration milestones that expand its MiniMed™ 780G system offerings. First, the agency cleared Medtronic’s SmartGuard™ algorithm as an interoperable automated glycemic controller (iAGC). This approval allows SmartGuard to work with Abbott’s Instinct sensor, giving people with type 1 diabetes a flexible option to automate blood sugar monitoring and insulin delivery.
Second, the FDA approved the MiniMed 780G system for adults aged 18 and older who have insulin-requiring type 2 diabetes. This marks the first time an advanced hybrid closed-loop system has been cleared for this group, offering automatic glucose adjustments throughout the day and night. Together, these approvals give more people living with diabetes access to technology that can reduce high and low blood sugar events and simplify diabetes management.
Read Announcement- Drug:
- MiniMed™ 780G
- Announced Date:
- April 18, 2025
- Indication:
- For people with type 1 diabetes
Announcement
Medtronic plc announced the U.S. Food and Drug Administration (FDA) approval for the Simplera Sync™ sensor for use with the MiniMed™ 780G system. With this approval, the MiniMed™ 780G system now offers more flexibility for users of the company's most advanced insulin delivery system featuring Meal Detection™ technology with both the Guardian™ 4 sensor and Simplera Sync™ sensor.
AI Summary
Medtronic plc recently received FDA approval for its new Simplera Sync™ sensor, designed for use with the MiniMed™ 780G system. This approval expands the system’s continuous glucose monitoring (CGM) options by allowing users to choose between the existing Guardian™ 4 sensor and the new Simplera Sync™ sensor.
The Simplera Sync™ is a disposable, all-in-one sensor that features a simple two-step insertion process and requires no fingersticks. Its introduction brings greater flexibility to Medtronic’s advanced insulin delivery system, which already incorporates Meal Detection™ technology to automatically detect rising blood glucose levels and adjust insulin delivery accordingly. The addition of this sensor is expected to enhance user convenience, offering more tailored diabetes management options ahead of its limited U.S. launch in fall 2025.
Read Announcement- Drug:
- MiniMed™ 780G
- Announced Date:
- June 21, 2024
- Indication:
- For people with type 1 diabetes
Announcement
Medtronic plc is presenting a comprehensive body of new data at the American Diabetes Association's (ADA) 84th Scientific Sessions that showcases the benefits of the MiniMed™ 780G system.
AI Summary
Medtronic plc is presenting new data at the ADA 84th Scientific Sessions that highlights the benefits of its MiniMed™ 780G system. The advanced insulin delivery system uses an algorithm that auto-corrects every five minutes to help manage blood sugar levels. Recent data shows that the system significantly reduces early morning hyperglycemia, or the dawn phenomenon, and improves overnight glucose control. It also decreases nighttime alerts, allowing for fewer sleep interruptions and better overall sleep quality, which is critical for people with type 1 diabetes.
The findings underscore how the MiniMed™ 780G system not only minimizes hyperglycemia but also eases the daily management burden for patients. Enhanced overnight performance and increased time in the target range are major benefits, making this innovative technology a promising tool in diabetes care and management.
Read Announcement
MiniMed FDA Regulatory Events
MiniMed is a drug developed by Medtronic for the following indication: Simplera Sync™ disposable, all-in-one sensor.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- MiniMed
- Announced Date:
- January 12, 2026
- Indication:
- Simplera Sync™ disposable, all-in-one sensor
Announcement
Medtronic announced U.S. Food and Drug Administration (FDA) 510(k) clearance of its MiniMed Go™ app.
AI Summary
Medtronic announced U.S. Food and Drug Administration (FDA) 510(k) clearance of the MiniMed Go™ app for its MiniMed Go™ Smart Multiple Daily Injection (MDI) system. The app links the InPen™ smart insulin pen with Abbott’s Instinct sensor to bring insulin dose data and continuous glucose readings together in one place, delivering real-time, personalized insights to users on injections.
Key features include missed-dose alerts, a dose calculator to simplify decisions, action-oriented guidance when doses are missed or miscalculated, and CareLink™ reporting to support easier collaboration with healthcare providers. Medtronic says these tools aim to reduce missed boluses and help people respond faster to high glucose events.
The system is cleared for people with insulin-requiring type 1 and type 2 diabetes aged 7 and older, and for children ages 2–6 under adult supervision. Compatibility of the Simplera™ sensor with MiniMed Go™ is under FDA review, and Medtronic expects a U.S. commercial launch this spring.
Read Announcement
BrainSense FDA Regulatory Events
BrainSense is a drug developed by Medtronic for the following indication: For people with Parkinson's through innovative brain-computer interface technology.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- BrainSense
- Announced Date:
- January 13, 2025
- Indication:
- For people with Parkinson's through innovative brain-computer interface technology
Announcement
Medtronic plc announced today CE (Conformité Européenne) Mark approval in the European Union (EU) and the United Kingdom (UK) for BrainSense™ Adaptive deep brain stimulation (aDBS) and BrainSense™ Electrode Identifier (EI), having achieved the standards required by the EU Medical Device Regulation (MDR).
AI Summary
Medtronic plc announced that its BrainSense™ Adaptive deep brain stimulation (aDBS) and BrainSense™ Electrode Identifier (EI) have received CE Mark approval in both the European Union (EU) and the United Kingdom (UK). This approval confirms that the products meet the rigorous standards required by the EU Medical Device Regulation (MDR). The technologies are designed to offer a closed-loop system that adjusts brain stimulation in real time, providing personalized treatment for Parkinson’s disease based on unique brain activity patterns. The system not only improves precision in initial programming but also allows clinicians to identify optimal electrode contacts quickly. With this milestone, Medtronic strengthens its position as a leader in innovative DBS technology, paving the way for improved management of Parkinson’s disease across Europe, with the technology expected to be available to patients in early 2025.
Read Announcement
InPen FDA Regulatory Events
InPen is a drug developed by Medtronic for the following indication: Smart insulin pen for multiple daily injections (MDI).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- InPen
- Announced Date:
- November 20, 2024
- Indication:
- Smart insulin pen for multiple daily injections (MDI)
Announcement
Medtronic plc announced U.S. Food and Drug Administration (FDA) clearance for its new InPen™ app featuring missed meal dose detection, paving the way for the launch of its Smart MDI system with the Simplera™ continuous glucose monitor (CGM).
AI Summary
Medtronic has received U.S. Food and Drug Administration clearance for its new InPen™ app that features missed meal dose detection. This innovative app is a key component of the upcoming Smart MDI system, which also includes the Simplera™ continuous glucose monitor (CGM). The Smart MDI system is the first of its kind to offer real-time, personalized recommendations on insulin dosing corrections for both missed and inaccurate mealtime doses.
The system is designed to help people with diabetes who use multiple daily injections manage their insulin dosing more effectively. By providing timely alerts and insights, the technology aims to reduce significant blood sugar spikes and decrease the risk of both short- and long-term complications. Medtronic plans to begin a limited market release, with a broader launch set to follow, making this a promising new tool for individuals managing diabetes daily.
Read Announcement
PulseSelect FDA Regulatory Events
PulseSelect is a drug developed by Medtronic for the following indication: To treat atrial fibrillation.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- PulseSelect
- Announced Date:
- September 27, 2024
- Indication:
- To treat atrial fibrillation
Announcement
Medtronic plc announced the presentation of clinical study results demonstrating a high rate of durable lesion formation for the PulseSelect™ Pulsed Field Ablation (PFA) System in treating atrial fibrillation (Afib).
AI Summary
Medtronic announced promising clinical study results for its PulseSelect™ Pulsed Field Ablation (PFA) System in treating atrial fibrillation (Afib). In a recent study of 25 patients, researchers performed invasive remapping about two months after the ablation. The results showed that 98% of pulmonary veins achieved durable lesion formation, while 96% of the patients had all veins isolated. This finding highlights the system’s ability to create lasting lesions, which is crucial for achieving successful pulmonary vein isolation and effective Afib treatment.
The study not only demonstrates the durability of the lesions created by the PulseSelect system but also reinforces its efficiency and safety in clinical practice. These results provide important real-world evidence for physicians, supporting the use of this innovative technology in improving long-term outcomes for patients with Afib.
Read Announcement
Affera™ FDA Regulatory Events
Affera™ is a drug developed by Medtronic for the following indication: for the treatment of persistent atrial fibrillation (AFib).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Affera™
- Announced Date:
- May 17, 2024
- Indication:
- for the treatment of persistent atrial fibrillation (AFib).
Announcement
Medtronic plc announced positive results demonstrating excellent safety and efficacy of the Affera™ Mapping and Ablation System with Sphere-9™ Catheter, an all-in-one pulsed field (PF) and radiofrequency (RF) ablation and high density (HD) mapping catheter for the treatment of persistent atrial fibrillation (AFib).
AI Summary
Medtronic plc has announced positive results from its SPHERE Per-AF trial, showcasing the safety and effectiveness of the Affera™ Mapping and Ablation System with the Sphere-9™ Catheter. This innovative device is an all-in-one solution that combines pulsed field (PF) and radiofrequency (RF) ablation with high density (HD) mapping, specifically designed to treat persistent atrial fibrillation (AFib).
The trial demonstrated that the Sphere-9 Catheter not only meets high safety standards—with minimal procedural complications—but also improves treatment efficiency and patient quality of life. Its design allows physicians to perform comprehensive pulmonary vein isolation and create precise ablation lesions with fewer tools and steps. These promising results bring Medtronic one step closer to receiving FDA approval, potentially transforming the way persistent AFib is treated in the U.S. and around the world.
Read Announcement- Drug:
- Affera™
- Announced Date:
- May 17, 2024
- Indication:
- for the treatment of persistent atrial fibrillation (AFib).
Announcement
Medtronic plc released results from the SPHERE Per-AF study comparing Sphere-9 to the conventional Thermocool SmartTouch SF radiofrequency ablation catheter with the Carto 3 System.
AI Summary
Medtronic recently released results from the SPHERE Per-AF study, a pivotal FDA Investigational Device Exemption (IDE) trial. The study compared the new Sphere-9 catheter with the established Thermocool SmartTouch SF radiofrequency ablation catheter paired with the Carto 3 System for treating persistent atrial fibrillation. The findings showed that the Sphere-9 catheter demonstrated an excellent safety profile with a primary safety endpoint of 1.4% and no serious adverse events such as pulmonary vein stenosis, esophageal events, or cardiac tamponade. Notably, the Sphere-9 allowed more than 95% of procedures to be completed with a single transeptal puncture, compared to only 62% with the control method. In terms of effectiveness, the study reported 73.8% freedom from AFib versus 65.8% with the conventional catheter, highlighting its enhanced efficiency in procedural time and energy delivery.
Read Announcement
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