ScandiDos AB (publ) listed on First North, is a world-leading company in quality assurance of modern radiation therapy through advanced measurement and calculation methods. ScandiDos AB announces it has received FDA 510 (k) clearance on its newest product, the Delta4 Phantom+ MR, therefore the product can now be marketed and sold in the U.S.

CEO Görgen Nilsson

ScandiDos has received the FDA 510 (k) clearance of its pre-treatment system, Delta4 Phantom+ MR. The US market represents at least 40% of the world market. In collaboration with the University of Utrecht, which is also the original initiator of MR-linac and Elekta's partner, ScandiDos has developed the new version of Delta4 Phantom+ for use in magnetic fields. Utrecht will present their clinical trials with the Delta4 Phantom+ MR at ESTRO in Milano on the 27th of April. For more information: https://delta4family.com/registration/estro38  

In addition to Elekta, MR-linacs are sold by the American company ViewRay. Elekta expects to have sold 70 MR-linacs through the summer of 2020 and our assessment is that ViewRay, which has been on the market for a longer period of time, will have sold at least as many systems.

Delta4 Phantom+ MR can now be sold in all major markets for MR-linac. Learn more about the product Delta4 Phantom+ MR.

For further information
Görgen Nilsson, CEO ScandiDos, Phone + 46-18-472 3030

Date: April 09, 2019