Mitria Medical’s Subvalvular Spacer reaches the U.S. under FDA compassionate use. What it means for FMR patients and what clinical evidence still needs to come.
Soterix Medical wins FDA clearance for SPRY TMS in treatment-resistant major depression. What the clearance means for the neuromodulation market. Read the analysis.
Life Recovery Systems (LRS), a medical device developer headquartered in Alexandria, Louisiana, has received an Investigational Device Exemption (IDE) from the U.S. Food and Drug Administration to advance its ThermoSuit System into a pivotal clinical trial enrolling ischemic stroke patients. The study, which will enroll up to 160 patients across as many as eight hospitals, […]
Eli Lilly and Company has announced a $3.5 billion investment to build a new injectable medicine and device manufacturing facility in Lehigh Valley, Pennsylvania. The site will focus on producing next-generation weight-loss medicines, including the investigational triple hormone receptor agonist retatrutide. Set to become operational by 2031, this is Lilly’s fourth new U.S. manufacturing site […]
Find out how UVDI’s V-MIX UV-C disinfection system is pushing upper-room air safety beyond hospitals into schools, offices, and airports.
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 […]
Can Aroa’s bioscaffold platform reshape trauma care economics? See what Myriad’s MASTRR data means for hospitals, surgeons, and reimbursement.
FDA clears PTOA risk reduction claim for Miach Orthopaedics’ BEAR Implant. Find out what this means for ACL treatment, patients, and future adoption.
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 […]