Industry News
Concept Medical Receives US FDA IDE Approval for MagicTouch AVF Indication
The approval covers the use of MagicTouch AVF for stenotic lesions of arteriovenous fistulas.
Ahmedabad: Gujarat-based Concept Medical announced Investigational Device Exemption (IDE) approval for its US FDA breakthrough-designated MagicTouch AVF. The indication covers the treatment of stenotic lesions of arteriovenous fistulas in the haemodialysis management of chronic renal failure.
The company has received four other US FDA IDE approvals for different indications in its MagicTouch product portfolio.
The AVF indication is the portfolio's fifth IDE approval.