www.fdanews.com/articles/197172-orfits-couch-top-for-proton-therapy-cleared-by-fda
Orfit’s Couch Top for Proton Therapy Cleared by FDA
May 18, 2020
The FDA has granted Orfit Industries 510(k) clearance for its Aerial couch top, a platform for cancer patients to lie on while receiving proton therapy.
The couch top positions and immobilizes the patients, and it can support individuals weighing up to 518 pounds.
Orfit previously received FDA clearance in 2015 for an immobilization system for patients with brain, head and neck tumors for use during proton therapy.