Industry News
The latest medical device regulatory news, clinical trials, and market insights
Critical Labeling Update Issued for Olympus Bronchoscopes Used in Laser Therapy Procedures
Olympus Corporation has announced a voluntary corrective action involving bronchoscopes used in conjunction with certain high-risk therapeutic procedures. This update…
Swissmedic Opens Bids for Advanced Document and Records Management System: A Regulatory Update
On November 3, 2025, Swissmedic, the Swiss agency for therapeutic products, announced its initiative to procure a state-of-the-art Document and…
FDA Restricts Sale of Unapproved Fluoride Prescription Drugs for Children’s Safety
The U.S. Food and Drug Administration (FDA) has announced significant regulatory steps to enhance child safety, restricting the sale of…
New FDA-Tracked POC EEG Device Advances Neurological Diagnostic Testing
The landscape of rapid neurological diagnostics is evolving with the announcement of a new handheld Point-of-Care (POC) Electro-Diagnostic Device at…
Upcoming K-SLEEP Trial to Explore Exogenous Ketones’ Effects on Sleep and Breathing Regulation
Johns Hopkins University partners with HVMN Inc. on a clinical trial investigating the impact of ketone supplementation on sleep and…
New Opportunities in Fetal Health: Exploring the NSR PregnaOne System Study
A groundbreaking study is underway, exploring the PregnaOne System, an in-home non-stress monitoring device dedicated to advanced fetal monitoring. ClinicalTrials.gov…
Investigational Trial of Non-FDA Approved Device Raises Questions for Regulatory Teams
Clinical device trials often prompt discussions regarding regulatory compliance, especially when the tested device lacks FDA approval or clearance. A…
Upcoming Observation Study on Burn Patients: Focus on TDAP and Sepsis Insights
On November 7, 2025, a compelling observational cohort study focused on burn patients, wound healing, and critical illness was highlighted.…
FDA Trial Underway for Experimental Medical Device: What You Need to Know
A new clinical trial for a medical device that has not yet received approval or clearance from the U.S. Food…
Validating Dozee: A Breakthrough in Contactless Monitoring of Vital Signs and Movement
On November 7, 2025, a noteworthy study validating the Dozee device for contactless monitoring of vital signs was announced. The…
Swissmedic Publishes November Safety Updates for Healthcare Professionals
Swissmedic has issued new safety-related updates this November 2025, designed to inform healthcare professionals and regulatory teams about important changes…
Swissmedic Updates Key Information on Drug Safety Reporting – What You Need to Know
Swissmedic has announced an update to its Drug Safety Reporting Duties in Switzerland information sheet. The adjustments include revised contact…