Abanza Inc. has received U.S. Food and Drug Administration (FDA) 510(k) clearance for QuadLock, its novel knotless fixation system for anterior cruciate ligament (ACL) reconstruction. The system, which features a bidirectional tension-adjustable design, reportedly offers over a 500% reduction in cyclic displacement compared to conventional fixation methods such as cortical buttons and interference screws, targeting […]
GT Medical Technologies has announced the first patient enrollments in its BRIDGES trial, a randomized clinical study assessing the use of GammaTile therapy in newly diagnosed glioblastoma. The trial introduces GammaTile at the time of initial tumor resection, marking a notable shift from the conventional glioblastoma radiation timeline, which typically delays radiation until several weeks […]
iotaMotion, Inc. has received U.S. Food and Drug Administration 510(k) clearance to expand the approved use of its iotaSOFT Robotic-Assisted Cochlear Implant Insertion System for children as young as four years old. This regulatory milestone makes the iotaSOFT system the first robotic-assisted cochlear insertion platform authorized for use in school-aged pediatric patients, expanding access to […]
CornerLoc has disclosed 6-month interim results from the ongoing SPARTAN Study evaluating its TransLoc 3D System, a lateral-oblique sacroiliac (SI) joint fusion platform. The data, published in the Pain Physician Journal, reported significant improvements in pain and function among enrolled patients, with no device-related or procedure-related adverse events during the evaluation period. The prospective multicenter […]
Avatar Medical is set to introduce Eonis Vision, a glasses-free 3D medical imaging system, at CES 2026. The product, developed in collaboration with Belgian display specialist Barco and powered by high-performance Dell hardware, is aimed at enhancing the clarity of doctor–patient communication. While the original Avatar Medical Vision software is already FDA-cleared, the updated version […]
XRlabs has disclosed it is integrating NVIDIA Jetson Thor and NVIDIA Isaac for Healthcare to develop an AI-powered retrofit system for surgical visualisation tools, aiming to deliver real-time perception, tool tracking, and intent-aware automation for neurosurgery and other minimally invasive procedures. The system is currently under early-stage clinical evaluation. Unlike traditional surgical robotics or integrated […]
Kallisio has begun clinical implementation of its FDA-cleared Stentra system at Stanford Health Care, marking the first reported integration of the patient-specific intraoral device into a major U.S. hospital’s workflow for head and neck cancer radiation therapy. The system, which received 510(k) clearance in January 2024, enables individualized immobilization of oral structures during intensity-modulated radiation […]
Find out how Establishment Labs is aiming to transform U.S. breast reconstruction with Motiva implants and FDA approval. Read what changes and risks lie ahead.
