Medical Devices
Federal judge upholds FDA authority over lab-developed tests
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.
FDA Approves New Hypertension Detection Device
Reported by AI
The U.S. Food and Drug Administration has approved a new device for detecting hypertension, integrating advanced sensor technology. This innovation aims to improve early diagnosis and management of the condition.
FDA Issues Breakthrough Designations
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.
AI Stethoscope Diagnoses Quickly
Reported by AI
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.