13 February 2026
13 February 2026
The decision by the EC was supported by data from the Myasthenia Gravis Inebilizumab Trial.
The device recently received clearance from the FDA under the 510(k) process.
The trial aims to enrol nearly 200 patients per arm, including those with diffuse large B-cell lymphoma.
TheraB Medical gained FDA clearance for SnugLit in January 2026.
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