Nuvectra seeking FDA conditional approval for full-body MR imaging for Algovita
Nuvectra (NASDAQ:NVTR) filed a regulatory submission with the FDA for conditional approval of full-body magnetic resonance (MR) imaging in patients implanted with the company’s Algovita spinal cord stimulation (SCS) system.
Algovita consists of 24-channel implantable pulse generators to manage pain.
“We believe full-body MR-conditional approval in the United States, in addition to Algovita’s full-body MR-conditional CE mark approval, will supplement our existing competitive advantages and expand the number of eligible patients,” Fred Parks, Nuvectra’s CEO, said in a statement.
Nuvectra expects the FDA’s decision around the end of 2019.