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Medical Device News Magazine is a comprehensive online resource for professionals in the medical device industry. Our editorial team provides readers with the latest regulatory news and updates from the FDA, as well as insights on product approvals, recalls, and alerts.
Elixir Medical Receives FDA Breakthrough Device Designation for the DynamX BTK System for Use in the Treatment of Chronic Limb-Threatening Ischemia Resulting From Below-The-Knee...
Elixir Medical advises the DynamX BTK System for the treatment of BTK vessels impacted by CLTI broadens the use of the novel bioadaptor platform technology beyond the treatment of coronary artery disease
FDA Approves First Gene Therapy for Children with Metachromatic Leukodystrophy
Metachromatic leukodystrophy is a debilitating, rare genetic disease affecting the brain and nervous system. It is caused by a deficiency of an enzyme called arylsulfatase A (ARSA), leading to a buildup of sulfatides (fatty substances) in the cells. This buildup causes damage to the central and peripheral nervous system, manifesting with loss of motor and cognitive function and early death. It is estimated that MLD affects one in every 40,000 individuals in the United States. There is no cure for MLD, and treatment typically focuses on supportive care and symptom management.
ADI Announces U.S. FDA 510(k) Clearance and the Commercial Launch of Sensinel by Analog Devicesâ„¢ Cardiopulmonary Management (CPM) System
Sensinel is a compact wearable device is a non-invasive, remote management system that captures cardiopulmonary measurements for chronic disease management such as heart failure. It is the first FDA clearance the company has received in its 59-year history.
Boston Scientific Receives FDA Approval for the AGENTâ„¢ Drug-Coated Balloon
The AGENT DCB is available in Europe, parts of Asia Pacific and Latin America for the treatment of patients with ISR and previously untreated small vessel coronary disease. Boston Scientific plans to launch the technology in the U.S. in the coming months.