U.S. Food and Drug Administration
PulseAI wins FDA clearance for wearable arrhythmia analysis model
PulseAI has received U.S. Food and Drug Administration 510(k) clearance for an AI-powered arrhythmia analysis model designed for wearable ECG devices. The Belfast…
Sleep apnea detection comes to the Galaxy Ring
Samsung’s updated sleep apnea feature is now available on the Galaxy Ring after approval from the U.S. Food and Drug Administration, the FDA, and Korea’s MFDS. The…
SimBioSys wins FDA clearance for AI breast cancer recurrence risk tool
SimBioSys has received FDA 510(k) clearance for TumorSight Risk, which the company describes as the world's first AI-powered, MRI-derived prognostic tool for breast…
RingConn Smart Ring Gets FDA 510(k) Clearance for Blood Oxygen Measurement
RingConn's Smart Ring has received 510(k) clearance from the U.S. Food and Drug Administration for non-invasive blood oxygen (SpO2) measurement. Shenzhen Ninenovo…
ResearchYamo Opens Autism Trial Registry After 6,000 Family Inquiries
Yamo Pharmaceuticals has opened a registration site for families interested in its planned Phase 3 program for L1-79, an investigational drug for the core symptoms of…
BusinessFDA to Modernize Quality Management on ComplianceQuest's AI Platform
The U.S. Food and Drug Administration will modernize its enterprise quality management operations on the ComplianceQuest platform, according to a joint announcement by…
FDA Clears HanchorBio's IND for HCB303, a Trispecific Cancer Immunotherapy
The U.S. Food and Drug Administration has cleared the investigational new drug application for HCB303, a trispecific immunotherapy from HanchorBio (TWSE: 7827), the…