Medical device company Delcath Systems lands Australian approval for its cancer-treatment system, and lands a definitive date with the FDA to review the device under a New Drug Application.

Medical device company Delcath Systems (NSDQ:DCTH) is on a roll, notching a couple new regulatory milestones this month for its organ-isolating ChemoSat chemotherapy treatment systems.

Delcath today announced that its 2nd-generation ChemoSat won regulatory approval from Australia's Therapeutic Goods Administration and that the FDA granted the company a June 13, 2013, date for standard review of its recently accepted New Drug Application.