Industry News
The latest medical device regulatory news, clinical trials, and market insights

FDA Issues Urgent Recall of Mega Ballast Medical Devices Due to Serious Health Risks
The FDA has flagged a critical recall concerning Balt USA’s Mega Ballast Distal Access Platform devices, identified as carrying a…

Sorcero Secures $42.5M Series B to Scale AI Healthtech Platform
Meta description: Sorcero raises $42.5M in Series B funding to expand its AI-driven medical data platform, strengthen compliance, and grow…

Urgent Swissmedic Batch Recall: Lexotanil 3mg Tablets
On 26 November 2025, Swissmedic issued an official notice regarding the immediate recall of batch 1653102 of Lexotanil 3mg Tablets.…

Swissmedic Grants Initial Authorisation for Tepezza®: Key Implications for Regulatory Teams
Swissmedic announces the first authorisation of Tepezza®. This development is significant for quality, clinical, and regulatory professionals monitoring approvals of…

Swissmedic Authorizes Temporary Distribution of Glucose 5% Infusion Solution in German Packaging
Swissmedic has announced a temporary approval for the distribution of Glucose 5% B. Braun Infusionslösung in German packaging. This decision…

Swissmedic Approves Temporary Distribution of NaCl 0.9% Infusion in Foreign Packaging
On November 26, 2025, Swissmedic announced the temporary approval for distribution of NaCl 0.9% infusion solution from B. Braun in…

Health Canada Aligns with IMDRF Standards for Medical Device Applications
In a significant step toward global regulatory alignment, Health Canada has announced it is adopting the International Medical Device Regulators…

Breakthrough Clinical Trial Evaluates High-Purity Type-I Collagen Scaffolds in Peritoneal Reconstruction
New advancements in peritoneal reconstruction may soon transform postoperative outcomes. A clinical trial, termed the SurgiPerito Trial, is now recruiting…

Advancing Pain Management: Ultrasound-Guided Interfascial Plane Blocks in Liver Donors
Researchers at Bahçeşehir University are driving innovation in perioperative care. A clinical trial is exploring the sensory effects and analgesic…

Clinical Update: Use of tDCS Devices in Degenerative Ataxia
Researchers at the University of Cagliari are exploring novel approaches to address degenerative ataxia through transcranial direct current stimulation (tDCS).…

Innovative Trial on Dysphagia Caregiver Web Tool Aims to Mitigate Burden
Northwell Health, in collaboration with the National Institute on Aging (NIA) and the National Institutes of Health (NIH), is moving…

Emerging Clinical Trial: GLP-1 Agonists Evaluated for Psoriatic Arthritis in Non-Diabetic Patients
A new clinical trial focusing on the use of GLP-1 receptor agonists for managing psoriatic arthritis in non-diabetic patients has…