Medical Devices
FDA Issues Breakthrough Designations
09. syyskuuta 2025 Raportoinut AI
The FDA granted several breakthrough device designations in September 2025 for innovative medical technologies. These designations expedite the development and review of devices addressing unmet needs. Updates include new approvals and predetermined change control plans.
Federal judge upholds FDA authority over lab-developed tests
05. lokakuuta 2025 Raportoinut AI
A U.S. federal judge has ruled that the Food and Drug Administration (FDA) possesses the authority to regulate lab-developed tests (LDTs) as medical devices. This decision comes amid ongoing debates over the oversight of in-house diagnostic tools used by clinical laboratories.
New Advances in Diabetes Management Technologies
Recent developments in diabetes care include smarter insulin delivery systems and an AI-paired artificial pancreas, highlighted on September 11, 2025.
AI Stethoscope Diagnoses Quickly
An AI-powered stethoscope was introduced, capable of diagnosing three conditions in 15 seconds. This innovation enhances point-of-care diagnostics in clinical settings. It was featured among key medical breakthroughs of the week.