Industry News
The latest medical device regulatory news, clinical trials, and market insights

Innovative fenoTRACK Device Monitors Fractional Exhaled Nitric Oxide in Asthma Management Study
On November 14, 2025, a new clinical trial involving the fenoTRACK device was announced, aimed at enhancing the management of…

Advances in Mixed-Reality for Neglect Diagnosis and Rehabilitation: Clinical Trial Update
A forthcoming clinical trial aims to leverage mixed-reality technology in diagnosing and rehabilitating neglect conditions, including sensory and hemispatial neglect.…

FDA Announces Appointment of Richard Pazdur as New CDER Director
The U.S. Food and Drug Administration (FDA) has confirmed that Dr. Richard Pazdur, a seasoned expert with 26 years of…

Unapproved Medical Device Under U.S. Clinical Trial Spotlight
On November 12, 2025, new attention turned to a clinical trial involving a medical device not yet approved or cleared…

Stanford Clinical Trial Explores Immersive Audio Biofeedback for Pain Management
Stanford University has announced an upcoming clinical trial that investigates the efficacy of immersive technology-based audio biofeedback for pain management.…

Predicting Daily Migraine Risk Using Machine Learning: Regulatory Insights
The completed clinical trial sponsored by Theranica and supervised by WCG IRB explored the application of machine learning in determining…

Innovative Clinical Investigation: NRX-101 and ONE-D TMS for Treatment-Resistant Depression
On November 12, 2025, an important announcement was made regarding an upcoming clinical trial that aims to address treatment-resistant depression…

Assessing Changes in Generalized Myasthenia Gravis Activity With VYVGART® Using Advanced BioDigit MG Metrics
On November 12, 2025, a new groundbreaking clinical trial was announced to investigate the impact of VYVGART® and VYVGART Hytrulo®…

Advancing Esophageal Care: Mucosal Impedance Testing in GERD and Eosinophilic Esophagitis
Clinical trial investigates new diagnostic option for chronic esophageal conditions. The Medical College of Wisconsin explores mucosal impedance testing for…

Digital Stethoscopes in Clinical Trials: Eko Study Targets Lung Conditions
A new clinical trial has been launched to evaluate the performance of Eko digital stethoscopes in detecting and monitoring lung…

Long-Term Safety and Effectiveness of VARIPULSE Catheter System: New Insights for Atrial Fibrillation Management
A new clinical study is seeking to assess the safety and effectiveness of the VARIPULSE Catheter System for long-term atrial…

Urgent Medicines Recall: Atorvastatin 20mg & 80mg Tablets from Sun Pharma Due to Stability Concerns
Sun Pharma UK Limited has issued a precautionary recall of specific batches of their Atorvastatin 20mg and 80mg film-coated tablets.…