EmpNia Receives FDA Clearance for eMotus™ Neuromodulation System
July 1, 2025
Regulatory Approval Paves the Way for U.S. Market Launch of Innovative Therapy Targeting Chronic Pain and Neurological Disorders
Regulatory Approval Paves the Way for U.S. Market Launch of Innovative Therapy Targeting Chronic Pain and Neurological Disorders
BOSTON, June 30, 2025 /PRNewswire/ — TOBY, Inc., a biotech startup advancing non-invasive cancer detection through urine-based volatilomics and Artificial Intelligence, announced today the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for its TOBY Test for Bladder Cancer.
New treatment option offers continuous symptom control for patients with advanced Parkinson’s disease, enhancing quality of life through minimally invasive drug delivery
Designed for long-term monitoring and patient comfort, EmbraceMini sets a new benchmark in wearable technology for decentralized and real-world evidence studies.
Next-Generation Ankle Replacement Platform Designed to Improve Surgical Precision and Patient Outcomes in Orthopaedic Care
Breakthrough Integrated Sacral Neuromodulation Device Approved to Treat Urinary Urge Incontinence with a Minimally Invasive, Patient-Centric Approach
Next-Generation Stent Designed to Prevent Stroke by Combining Embolic Protection and Advanced Plaque Management in Carotid Artery Disease
CHICAGO, June 25, 2025 /PRNewswire/ — Sysmex America, Inc., a leading diagnostic solutions company offering hematology, hemostasis, urinalysis, flow cytometry and informatic solutions, has received FDA clearance for the CN-6000™ Automated Blood Coagulation Analyzer.
Tissium announced today that it received FDA de novo marketing authorization for Coaptium Connect with Tissium Light.
Vivasure Medical announced today that it submitted its PerQSeal Elite vascular closure system to the FDA for premarket approval (PMA).