Industry News
The latest medical device regulatory news, clinical trials, and market insights
CaRi-Heart® Analysis for Precise Cardiovascular Risk Assessment: New Clinical Trial Update
The upcoming clinical trial for the innovative CaRi-Heart® Analysis is set to redefine risk assessment in coronary artery disease, atherosclerosis,…
Innovative Digital Phenotyping Study for Adolescent Cancer Patients Under Development
Stanford University is spearheading a new clinical trial titled Digital Phenotyping for Psychosocial Screening in Adolescents and Young Adults With…
Advancement in Epilepsy Care: Exploring Trigeminal Nerve Stimulation
On October 23, 2025, ongoing developments in epilepsy treatment reached a new milestone with an update from the trial sponsored…
Regulatory Spotlight: Gut Microbiota Studies Incorporating Mini-Pill Device Innovations
Clinical trials are advancing the intersection of gut microbiota research and medical devices with new studies evaluating plant-based and meat-based…
Swissmedic Approves Initial Authorization for Sogroya®: Key Details for Regulatory Professionals
Swissmedic has announced the first authorization for Sogroya®, marking a significant regulatory development. The approval introduces a new option within…
Unapproved Medical Device Trial: What Clinical Teams Need to Know
A recent clinical trial involving a medical device that has not yet been approved or cleared by the U.S. Food…
Innovative Monochromatic X-Ray Mammography Trial Targets Breast Cancer Detection Advancements
A clinical trial investigating the innovative 2-D Monochromatic X-ray Mammography System has been listed on ClinicalTrials.gov, marking an important step…
Innovative iTBS Study Targets Enhanced Cognitive Function in Adolescent ADHD
Bradley Hospital has initiated a groundbreaking clinical trial exploring accelerated intermittent theta burst stimulation (iTBS) as a tool to improve…
Investigational Use of Non-FDA Cleared Device Under Clinical Trial Evaluation
A new clinical trial involves the testing of a medical device that has not been cleared or approved by the…
Advancing the Future of Lower GI Tract Imaging: Pilot Study Launch of Retrograde Tethered Capsule Endomicroscope Device
Massachusetts General Hospital has initiated a groundbreaking clinical trial focusing on imaging the lower gastrointestinal (GI) tract. Utilizing a novel…
Critical Updates: Field Safety Notices Issued for Medical Devices (13–17 October 2025)
Field Safety Notices (FSNs) issued between 13 and 17 October 2025 have been published, bringing critical updates for clinical, quality,…
Swissmedic Update: Revised EU Medical Device Regulations Explained
On October 21, 2025, Swissmedic announced updates to key sections related to EU legal acts for medical devices. These revisions…