Industry News
The latest medical device regulatory news, clinical trials, and market insights
FDA Grants Historic National Priority Vouchers to Nine Sponsors Under New Pilot Program
The U.S. Food and Drug Administration (FDA) has announced a significant development in regulatory initiatives. On October 18, 2025, the…
Swissmedic Announces Limited Distribution Approval for Opdivo 40 mg/4 ml Infusion Concentrate Amid Supply Challenges
Swissmedic has issued a temporary authorization permitting the distribution of Opdivo 40 mg/4 ml Konzentrat zur Herstellung einer Infusionslösung in…
FDA Warns of Serious Risks Linked to Radiofrequency Microneedling Devices for Aesthetic Skin Procedures
The U.S. Food and Drug Administration (FDA) has issued a safety communication concerning serious complications associated with the use of…
BridGene Biosciences Secures $28M Series B+ Funding to Advance Clinical Pipeline and Platform Expansion
Meta description: BridGene Biosciences has raised $28 million in Series B+ funding to drive clinical progress for oncology programs and…
Urgent Recall of Similasan Schnupfen Globuli Batch 17900 Announced by Swissmedic
On October 16, 2025, Swissmedic issued an urgent announcement regarding the recall of batch 17900 of Similasan Schnupfen Globuli (15g),…
AI-Powered ECG Advances Cardiac Device Risk Prediction in Groundbreaking Clinical Study
In a major development for cardiac device management and diagnostics, a new clinical study from the National Defense Medical Center…
BNP Testing Completes Performance Validation for Heart Failure Diagnostics
Clinical evaluation of BNP testing confirms concordance and reliability for heart failure diagnosis. Beckman Coulter, Inc. has officially completed a…
Regulatory Focus: Enhancing Healthcare Integrity Through Validator Tools and Whistleblower Pathways
On October 16, 2025, Truway Health, Inc. unveiled critical advancements in healthcare fraud enforcement protocols through a trial designed to…
Dialysis Fluid Management Advances: Clinical Trial for ESRD Patients by HemoCept Inc.
Published on October 16, 2025 A new clinical trial is underway aiming to improve dialysis fluid management in patients with…
Advancing Commissural Alignment: Evolut FX+ TAVI Device Trial Announced
Oslo University Hospital has revealed details about a newly devised clinical trial focusing on commissural alignment optimization during transcatheter aortic…
Advancing Cardiac Care: Left Bundle Branch Area Pacing Study Now Recruiting
Abbott Medical Devices has announced recruitment for a pivotal clinical trial investigating Left Bundle Branch Area Pacing (LBBAP) in cardiac…
Critical Updates on Field Safety Notices Issued from 6–10 October 2025
Between 6 October and 10 October 2025, several Field Safety Notices (FSNs) were published, signaling important updates and concerns for…