Devices

Medtronic Wins Expanded Clearance for AXiS System

FDA has cleared a Medtronic 510(k) for its Stealth AXiS surgical system in cranial and ear, nose and throat procedures, extending the reach of a platform the company is positioning as a unified navigation and robotics hub across surgical specialties. The latest clearance follows an earlier nod for spine procedures in February, marking another step in Medtronic’s push to consolidate surgical planning, navigation and robotics into a single system.

Stealth AXiS combines image-guided navigation with robotic assistance and AI-enabled software, part of what the company calls its broader AiBLE ecosystem. The device is designed to provide surgeons with real-time intraoperative insights and preoperative planning tools, particularly for anatomically complex procedures.

In cranial surgery, the company says the platform includes AI-driven tractography capabilities that generate patient-specific brain maps, helping surgeons visualize critical neural pathways before and during procedures. The system also integrates intraoperative imaging through GE HealthCare’s ultrasound technology, adding another layer of real-time guidance.

For ENT procedures, Medtronic is emphasizing improved visualization and navigation tailored to the sinus and skull base, areas where precision is critical and margins for error are narrow.

Unlike traditional robotic systems focused on a single specialty, Medtronic says its Stealth AXiS was developed as a modular platform that can expand across indications through software updates and additional capabilities, potentially allowing Medtronic to scale adoption within hospitals already using its navigation systems.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome