Medtronic Stock Price, News & Analysis

Medtronic (NYSE: MDT) has received FDA clearance for its new InPen™ app with missed meal dose detection, enabling the launch of its Smart MDI system with Simplera™ CGM. The system combines a smart insulin pen with a new disposable CGM that's 50% smaller than previous versions. This marks the first system to provide real-time, personalized recommendations for missed or inaccurate insulin doses. The technology addresses a critical need, as patients typically miss 1 in 3 insulin doses. The company plans a phased rollout, starting with existing CGM and InPen™ customers before a broader commercial launch.

Medtronic (MDT) reported strong Q2 FY25 results with revenue of $8.4 billion, up 5.3% as reported and 5.0% organic. GAAP EPS was $0.99, while non-GAAP EPS reached $1.26. The company raised its FY25 guidance, now expecting organic revenue growth of 4.75-5% and non-GAAP EPS of $5.44-$5.50.

Growth was driven by innovation across key franchises including TAVR, PFA, Leadless Pacemakers, Diabetes, Spine, and Neuromodulation. The Cardiovascular portfolio grew 6.1%, Neuroscience increased 7.1%, Medical Surgical rose 1.2%, and Diabetes jumped 12.4%. Strong performance in international markets and continued adoption of new products contributed to the positive results.

Medtronic (NYSE:MDT) has announced it will release its second quarter fiscal year 2025 financial results on Tuesday, November 19, 2024, at approximately 5:45 a.m. CST. The company will host a video webcast at 7:00 a.m. CST to discuss the results. The fiscal quarter ended on October 25, 2024. Future earnings releases are scheduled for February 18, 2025 (Q3) and May 21, 2025 (Q4). Medtronic, headquartered in Galway, Ireland, operates across 150+ countries with 95,000+ employees, providing technologies and therapies that treat 70 health conditions.

Medtronic (NYSE: MDT) announced that the Centers for Medicare & Medicaid Services (CMS) has granted transitional pass-through (TPT) payment for its Symplicity Spyral™ renal denervation catheter, effective January 1, 2025, for up to three years. The TPT approval aims to improve patient access to this breakthrough treatment for uncontrolled high blood pressure by reducing cost barriers for healthcare systems. The device, FDA-approved in November 2023, is a minimally invasive procedure that uses radiofrequency energy to calm overactive kidney nerves contributing to high blood pressure. The system is currently approved in over 75 countries and has been used to treat more than 25,000 patients globally.

Medtronic (NYSE: MDT) announced new two-year data from its SPYRAL HTN-ON MED clinical trial showing significant blood pressure reductions using the Symplicity™ Spyral renal denervation (RDN) system. The study demonstrated superior results compared to sham patients, with RDN group showing -12.1 mmHg reduction in 24-hr ABPM versus -7.0 mmHg in sham group. The company also announced plans for the SPYRAL GEMINI clinical trial to study multi-organ denervation, and the expansion of the GSR-DEFINE clinical trial to U.S. sites. The Symplicity Spyral system is currently approved in over 75 countries.

Medtronic (NYSE: MDT) has received FDA approval for its Affera™ Mapping and Ablation System with Sphere-9™ Catheter, making it the first company with two pulsed field ablation (PFA) technologies for atrial fibrillation treatment. The system combines high-density mapping with dual energy (pulsed field and radiofrequency) ablation capabilities for treating persistent atrial fibrillation and atrial flutter. The Sphere-9 catheter features a 9mm lattice tip and enables physician treatment flexibility with its wide area focal design. The approval follows successful results from the SPHERE Per-AF study and previous CE Mark and Australian approvals.

Medtronic employees surprised 200 students in Columbia Heights with new bikes, locks, and helmets. This donation was part of a volunteer effort where hundreds of Medtronic employees built the bikes. The initiative continues the legacy of Medtronic's founder, Earl Bakken, who grew up in Columbia Heights and inspired employees to contribute to their communities.

This bike donation is one of many efforts by Medtronic to create lasting change in communities. The company encourages its employees to give back and make an impact across various communities, following Bakken's vision of community involvement.

Medtronic (NYSE: MDT) has issued a voluntary recall for its MiniMed™ 600 and 700 series insulin pumps due to potential risks of shortened battery life. The recall, initiated on July 31, 2024, urges users to monitor built-in alerts and alarms for battery status and contact Medtronic for replacements if battery life issues are observed. The issue stems from internal electrical component damage caused by drops or impacts, leading to premature battery depletion. This can result in the pump stopping insulin delivery earlier than expected, posing health risks like hyperglycemia or diabetic ketoacidosis (DKA). From January 2023 to September 2024, there were 170 reports of hyperglycemia and 11 reports of DKA in the U.S. related to this issue. The FDA has classified this recall as a class I recall. Medtronic advises users to carry extra batteries and contact support if they notice significant battery life reduction.

Medtronic plc (NYSE: MDT) announced new clinical data for its PulseSelect™ Pulsed Field Ablation (PFA) System in treating atrial fibrillation (Afib). The study, presented at the Asia Pacific Heart Rhythm Society (APHRS) meeting, showed high rates of durable lesion formation:

- 98% of pulmonary veins remained isolated
- 96% of patients had all veins isolated

These results were observed approximately two months post-ablation. Dr. Devi Nair, Director of Cardiac Electrophysiology & Research at St. Bernard's Medical Center, emphasized the importance of this real-world evidence for the electrophysiology community as PFA use increases rapidly. The data adds to previous evidence establishing the safety and effectiveness of the PulseSelect technology.