MedTech News
FDA Grants Breakthrough Device Designation to TOBY’s AI-Powered Urine Test for Early Bladder Cancer Detection
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 method combines imaging and sequencing to study gene function in intact tissue
The approach collects multiple types of imaging and sequencing data from the same cells, leading to new insights into mouse liver biology.
AI model spots gastric cancer on routine CT scans with high accuracy, outperforming radiologists
A collaboration of leading Chinese research institutions has developed an artificial intelligence-based method called GRAPE, demonstrating high accuracy in detecting gastric cancer from routine noncontrast CT scans.
AI-assisted technique offers effective and painless breast imaging alternative
A Caltech-led team has developed a safe, effective, and painless breast imaging technique that incorporates machine learning to help differentiate between suspicious and healthy tissue.
Hollywood-inspired motion capture helps transform mouse modeling for neurological research
Mouse models are central to drug development, including treatments for neurological disorders, such as Parkinson’s disease. Such diseases often affect movement, and treatments may need to relieve symptoms such as tremors.
AI tool detects 9 types of dementia from a single brain scan
Mayo Clinic researchers have developed a new artificial intelligence (AI) tool that helps clinicians identify brain activity patterns linked to nine types of dementia, including Alzheimer’s disease, using a single, widely available scan—a transformative advance in early, accurate diagnosis.
Convatec Secures U.S. FDA Approval for Subcutaneous Apomorphine Infusion Therapy
New treatment option offers continuous symptom control for patients with advanced Parkinson’s disease, enhancing quality of life through minimally invasive drug delivery
Empatica Launches EmbraceMini: World’s Smallest Actigraphy Wearable for Clinical Trials
Designed for long-term monitoring and patient comfort, EmbraceMini sets a new benchmark in wearable technology for decentralized and real-world evidence studies.