The topical treatment is made from human skin cells and can be applied to speed the healing of deep thermal burns.
A topical burn treatment from Mallinckrodt plc division Stratatech Corporation has been approved by the US Food and Drug Administration.
StrataGraft is indicated to treat adults with thermal burns in which some deep skin layers remain intact, also known as deep partial thickness burns. The therapy is produced from two...
Second submission window for joint scientific consultations on a procedure to help prepare for joint clinical assessments will open from 2 to 30 June 2025.
During MD&M East last week, regulatory consultant Darren Reeves reminded device manufacturers that the time to get ready to comply with the new Quality Management System Regulation is now.
Speakers at a recent UK medtech outlook conference voiced optimism about the sector’s prospects, but warned that cost burdens, over-regulation and lengthy processes will impede the capacity of local SMEs to innovate. Only 10% of NHS procured medtech comes from UK manufacturers.
