Medtronic | MedPath

GV20 Therapeutics to Present AI-Designed Immune Checkpoint Inhibitor Data for Advanced Melanoma at ASCO 2025

14 hours ago

• GV20 Therapeutics will present updated Phase 1 data on GV20-0251, the first AI-designed antibody targeting the novel immune checkpoint IGSF8, at ASCO 2025. • The presentation will showcase clinical and translational findings from patients with advanced solid tumors resistant to anti-PD(L)1 therapies, with a focus on melanoma patients showing primary resistance. • GV20-0251 represents a significant advancement in AI-driven drug discovery, having progressed from target identification to IND filing in just three years with promising early efficacy data.

Medtronic's Affera™ PFA Technologies Show Promising Results for Atrial Fibrillation Treatment

a month ago

• One-year clinical trial data for Medtronic's investigational Sphere-360™ single-shot PFA catheter demonstrated 88% freedom from arrhythmia recurrence in paroxysmal atrial fibrillation patients, with no reported safety events in the optimized waveform subgroup. • The Sphere-9™ catheter, which received FDA approval in October 2024, has shown efficacy for linear ablation in persistent atrial fibrillation patients, offering physicians treatment flexibility with its wide area focal design. • Medtronic continues to strengthen its position in electrophysiology as the only company with two pulsed field ablation offerings, addressing a condition that affects more than 60 million people worldwide.

Medtronic's Hugo Robotic Surgery System Meets Primary Endpoints in Landmark Urologic Trial

a month ago

• Medtronic's Expand URO clinical trial, the largest multi-center prospective IDE study for robotic-assisted urologic surgery in the U.S., successfully met both primary safety and effectiveness endpoints with 137 patients. • The Hugo RAS system demonstrated impressive safety outcomes with complication rates significantly below performance goals across all procedure types, and achieved a 98.5% surgical success rate, well above the 85% performance goal (p<0.0001). • Medtronic has submitted the Hugo RAS system to the FDA for urologic indications in Q1 2025, marking a significant step toward entering the U.S. market while continuing to expand its global presence across 25 countries.

FDA Approves Medtronic's OmniaSecure: World's Smallest Defibrillation Lead for Cardiac Patients

a month ago

• Medtronic has received FDA approval for OmniaSecure, the world's smallest defibrillation lead at 1.6mm diameter, designed for placement in the right ventricle to treat life-threatening cardiac arrhythmias. • The novel lead is indicated for patients 12 years and older, including those with smaller anatomies, and connects to implantable defibrillators to restore normal heartbeat in conditions like ventricular tachyarrhythmias. • Medtronic is also investigating OmniaSecure's placement in the left bundle branch area, with preliminary clinical study results showing 100% defibrillation success at implant, potentially enabling more physiologic pacing that mimics natural heart conduction.

Medtronic Submits Interoperable Insulin Pump to FDA, Advancing Abbott Partnership

a month ago

• Medtronic has submitted 510(k) applications to the FDA for its MiniMed 780G pump as an alternate controller enabled device and its SmartGuard algorithm as an interoperable automated glycemic controller. • The regulatory submissions mark a significant milestone in Medtronic's collaboration with Abbott, which will supply a continuous glucose monitoring sensor based on its most advanced CGM platform. • If cleared, the interoperable system would represent a strategic shift for Medtronic, which previously focused on pairing only its own devices, now offering patients more device integration options.

FDA Approves Medtronic's Simplera Sync Sensor for MiniMed 780G System, Expanding CGM Options for Diabetes Management

a month ago

• The FDA has approved Medtronic's Simplera Sync sensor for use with the MiniMed 780G insulin delivery system, expanding continuous glucose monitoring options for diabetes patients in the U.S. • The Simplera Sync is a disposable, all-in-one sensor requiring no fingersticks with SmartGuard or overtape, featuring a simplified two-step insertion process designed to enhance user experience. • Medtronic plans a limited U.S. launch of the Simplera Sync sensor in fall 2025, complementing the existing Guardian 4 sensor compatibility with the MiniMed 780G system.

Medtronic's Evolut TAVR System Demonstrates Superior Durability and Performance at Five-Year Mark

2 months ago

• Medtronic's Evolut TAVR system showed comparable rates of all-cause mortality or disabling stroke to surgical valve replacement at five years (15.5% vs 16.4%), with numerically lower cardiovascular mortality rates. • The self-expanding Evolut valve demonstrated significantly larger effective orifice areas and lower mean gradients compared to surgical valves, reinforcing its superior hemodynamic performance in low-risk aortic stenosis patients. • These five-year outcomes, presented at the American College of Cardiology's Annual Scientific Session, support Evolut TAVR as a durable alternative to surgery regardless of surgical risk, potentially shifting treatment paradigms for younger patients.

First Ascent Biomedical Secures Florida Grant to Expand AI-Driven Cancer Treatment Platform

3 months ago

• First Ascent Biomedical's xDRIVE Drug Prediction Platform, showing 83% improvement in treatment outcomes, receives funding from Florida Cancer Innovation Fund to expand personalized cancer care access. • The AI-powered platform combines DNA/RNA sequencing, drug sensitivity testing, and machine learning to identify optimal treatments for cancer recurrence, with notable success in pediatric oncology. • The grant will support expanding treatment access to rural and minority communities in Florida, while advancing FDA Breakthrough Device Designation and insurance coverage approvals.

Medable Secures CNIL Approval for Digital Clinical Trial Solutions in European Union

3 months ago

• Medable Inc. has received CNIL approval to operate its eConsent and eCOA solutions in eight countries outside the EU, marking a significant expansion of digital clinical trial capabilities. • The company partnered with French pharmaceutical giant Servier to achieve this regulatory milestone, demonstrating platform validation and enhanced security measures through a rigorous six-month process. • Medable's digital platform has shown impressive results across 300+ trials globally, including 90% eCOA adherence and potential ROI of up to $39 million for Phase III trials.

Medtronic Launches Global Trial for Prevail Drug-Coated Balloon in Coronary Artery Disease

3 months ago

• Medtronic has initiated patient enrollment in a global trial evaluating the Prevail paclitaxel-coated balloon catheter for treating in-stent restenosis and small vessel disease in coronary artery disease patients. • The trial aims to enroll 1,205 patients across the US, Europe, and Asia, with the primary endpoint measuring target lesion failure at one year post-treatment. • The Prevail DCB, already CE-marked since 2001, could potentially gain FDA approval in the United States, where coronary drug-coated balloons are just beginning to gain regulatory acceptance.

Epicore Biosystems Secures $32M in Expanded Series B for Advanced Sweat-Sensing Wearable Technology

3 months ago

• Epicore Biosystems has raised an additional $6M in Series B funding, bringing the total to $32M to accelerate global expansion of its sweat-sensing wearable technologies. • The company's Connected Hydration platform measures sweat composition, fluid losses, and physiological markers to detect early signs of fatigue and heat exhaustion, with applications validated in Nature Digital Medicine. • Epicore plans to expand into industrial markets across Australia, the Middle East, and Asia while scaling cloud analytics and validating novel biomarkers for kidney health and stress management.