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
Affera™, BrainSense, Inceptiv, InPen, MiniMed™, and PulseSelect. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Affera™ - FDA Regulatory Timeline and 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 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- 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.
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BrainSense - FDA Regulatory Timeline and 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.
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Inceptiv - FDA Regulatory Timeline and Events
Inceptiv is a drug developed by Medtronic for the following indication: to treat chronic pain.
This drug is approved by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Inceptiv
- Announced Date:
- April 26, 2024
- Indication:
- to treat chronic pain
Announcement
Medtronic plc announced that the U.S. Food and Drug Administration (FDA) has approved the Inceptiv™ closed-loop rechargeable spinal cord stimulator (SCS) for the treatment of chronic pain. Inceptiv is the first Medtronic SCS device to offer a closed-loop feature that senses biological signals along the spinal cord and automatically adjusts stimulation in real time, keeping therapy in harmony with the motions of daily life.
AI Summary
The U.S. Food and Drug Administration (FDA) has approved Medtronic plc’s new Inceptiv™ closed-loop rechargeable spinal cord stimulator (SCS) for treating chronic pain. This is the first Medtronic SCS device equipped with a closed-loop feature that continuously senses biological signals along the spinal cord and automatically adjusts the stimulation in real time.
This advanced capability means the therapy adapts instantaneously to the body’s movements, ensuring that pain management stays in perfect sync with daily activities. Unlike traditional fixed-output SCS devices, which can sometimes cause moments of overstimulation during actions like bending or laughing, the Inceptiv SCS maintains the precise stimulation level prescribed by doctors. This breakthrough technology offers personalized pain relief and enhances the overall treatment experience for patients managing chronic pain.
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InPen - FDA Regulatory Timeline and 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.
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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:
- 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.
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PulseSelect - FDA Regulatory Timeline and 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.
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