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OTHER NEWS

SetPoint Medical Accepted into FDA Total Product Life Cycle Advisory Program for Development of its Neuroimmune Modulation Platform for the Treatment of Multiple Sclerosis

SetPoint Medical notes acceptance into the TAP Pilot will help expedite regulatory and patient access pathways for a first-of-its-kind therapeutic approach for people with relapsing-remitting multiple sclerosis.TAP Pilot acceptance follows Breakthrough Device Designation announcement for the treatment of RRMS.

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.

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