Industry News
The latest medical device regulatory news, clinical trials, and market insights
Swissmedic Approves Extended Therapeutic Indication for Omvoh®
Swissmedic has announced an important update regarding the therapeutic scope of Omvoh®. The newly approved indication offers enhanced application potential…
Safety Alert: Recall of NaCl B. Braun Infusion Solution Batch
Swissmedic has issued an announcement regarding the immediate recall of batch number 251347651 of NaCl B. Braun infusion solution. This…
Advancing Lumbar Interbody Fusion: CORUS-LX System Under Regulatory Evaluation
The CORUS-LX System is embarking on a critical phase of its journey to improve lumbar interbody fusion outcomes. As of…
Advancing Esophageal Cancer Care: A Clinical Trial to Evaluate Liquid Nitrogen Spray Cryotherapy
Liquid Nitrogen Spray Cryotherapy (LNSC) combined with systemic therapy offers new hope for patients battling esophageal adenocarcinoma. A groundbreaking clinical…
Breakthrough Trial: Masimo’s Irregular Heartbeat Detection Technology Tested for Regulatory and Clinical Validation
Masimo Corporation has officially commenced recruitment for its clinical trial evaluating the accuracy of its irregular heartbeat detection algorithm in…
Innovative Approach to Promoting Physical Activity in Pregnant Women: Regulatory Insights
On October 31, 2025, an exciting new clinical trial was announced that aims to address a critical health challenge—how to…
Targeted Approach to Boost Medication Adherence in Adolescents and Young Adults with Cancer
A new clinical trial is set to begin recruitment, aiming to improve medication adherence among adolescents and young adults living…
FDA Accelerates Biosimilar Approvals to Cut Treatment Costs for Chronic Diseases
The U.S. Food and Drug Administration (FDA) has announced measures to streamline the development of biosimilar drugs. These steps aim…
Innovative Device Offers Non-Invasive Solution for Intracranial Pressure Estimation
Clinical trial updates: A new approach to estimating intracranial pressure (ICP) has been introduced through ongoing studies. The CPMX3 device,…
Regulatory Advances in NIRS Monitoring for Neonatal AKI Management
NYU Langone Health is presently recruiting patients for a groundbreaking investigation into the application of Near-Infrared Spectroscopy (NIRS) monitoring in…
Unapproved Medical Device Trial Raises Questions for Compliance Teams
A clinical trial is underway involving a medical device that has not yet received U.S. FDA approval or clearance. This…
MoblO2 Device Trial Announced to Address Oxygenation in Chronic Respiratory Conditions
A recent announcement sheds light on a new clinical trial intended to evaluate the MoblO2 medical device for maintaining oxygenation…