Industry News
The latest medical device regulatory news, clinical trials, and market insights
New Clinical Trial Aims to Evaluate the SOFIA Flow 88 Catheter for Acute Ischemic Stroke
Meta description: Learn about the upcoming clinical trial evaluating the SOFIA Flow 88 Aspiration Catheter for large vessel occlusions in…
Innovative Photoacoustic Device Targets Improved Foot Ulcer Diagnostics
New research highlights advancements in photoacoustic imaging for foot ulcers, paving the way for potential improvements in early diagnosis and…
Unapproved Medical Device Trial Raises Critical Regulatory and Clinical Questions
A clinical trial involving a medical device that has not yet been approved or cleared by the U.S. FDA is…
Pioneering VR-Assisted Deep Brain Stimulation Trial for PTSD and Anxiety Disorders
Published: October 14, 2025 A groundbreaking study is advancing the use of deep brain stimulation (DBS) technology to address PTSD…
FDA Trial Conducted for Unapproved Medical Device Raises Regulatory and Safety Questions
Clinical teams and regulatory experts: A new clinical trial involving a medical device not yet cleared or approved by the…
Upcoming Sleep Health Study in Pregnant Women Raises Important Questions for Clinical Practice
A new observational cohort study focused on sleep health in pregnant women is set to begin recruitment under the sponsorship…
Emerging Blood Pressure Monitoring Technologies: Insights from The Continuity Study
The clinical trial landscape is set to expand with Edwards Lifesciences introducing The Continuity Study, designed to evaluate groundbreaking devices…
Swissmedic Highlights Regulatory Focus on Parenteral Cosmetic Products
Swissmedic has released key insights on parenteral products in the cosmetic sector. This update, published on October 13, 2025, emphasizes…
FDA Issues Boxed Warning Update for CARVYKTI Over Rare Enterocolitis Risk
The U.S. Food and Drug Administration (FDA) has issued updated labeling for Ciltacabtagene Autoleucel (CARVYKTI), a treatment for certain patients…
Urgent FDA Alert: Cybersecurity Vulnerability Identified in Abiomed’s Automated Impella Controller
On October 10, 2025, the FDA issued an alert regarding a cybersecurity vulnerability affecting the Automated Impella Controller (AIC) used…
CSMD-Horizon 2025 to Address MedTech AI, Digital Health and Regulation in Brussels
The CSMD-Horizon Special Conference for MedTech AI and Digital Health: Regulation, Market Access and Clinical Evidence will take place on…
Swissmedic Grants First Authorization for Balversa® in Targeted Cancer Treatment
On October 10, 2025, Swissmedic issued its first authorization for Balversa®, marking a significant milestone in precision oncology. This pivotal…