Ortho Regenerative Technologies announced that following a formal meeting with FDA, an IND can be submitted in parallel with completion of a pivotal study on Ortho-R biopolymer for rotator cuff repair.
Alphatec received FDA 510(k) clearance to market automated SafeOp neuromonitoring for use in real-time intra-op nerve location and health assessment. Commercial launch will occur within 1H19.