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Concept Medical’s fourth IDE approval for the MagicTouch Sirolimus Coated Balloon is granted for the treatment of Superficial Femoral Artery Disease

The US FDA, on the 24th of May 2023, granted an Investigational Device Exemption (IDE) approval for Concept Medical Inc's Sirolimus Coated Balloon (SCB) MagicTouch PTA for the treatment of...

Brexogen’s Exosome Therapy for Atopic Dermatitis, ‘BRE-AD01’ Accepted for Phase 1 Clinical Trials

The US FDA granted the initiation of the phase 1 clinical trial of 'BRE-AD01', an exosome- based therapy for atopic dermatitis. 'BRE-AD01' is being...

Werfen Receives US FDA 510(K) Clearance for Rotem Sigma Thromboelastometry System

Werfen announced the 510(k) clearance of the ROTEM sigma Thromboelastometry System by the US Food and Drug Administration (FDA). The ROTEM sigma delivers real-time,...
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