BioTuesdays

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.

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