The study will examine the safety and efficacy of Sooma Medical's device, Sooma 2GEN, in improving MDD as a home-based treatment. The device, worn as a cap, uses tDCS therapy, a non-invasive technique ...

Professional services consultancy, Procorre is urging the Medical Devices industry to take action ahead of the new ISO13485:2016 International Standard and MDD & IVD ‘Recast’ which become mandatory in ...

Can New Devices be Approved from Single Arm Studies: Use of Real-World Data as an External Control Group or for Propensity Matching or Generating Objective Performance Criteria Receive the the latest ...

Cynosure, Inc. (NASDAQ: CYNO), a leader in laser- and light-based aesthetic treatments, today announced that it has received European Medical Device Directive (MDD) certification from its European ...

BOSTON, March 11, 2025 /PRNewswire/ -- Lindus Health, the "anti-CRO" running radically faster, more reliable clinical trials for life science pioneers, and Sooma Medical, a world-leading provider of ...