Spineology announced that 24-month outcomes from its Scout clinical trial for interbody fusion revealed substantial improvements in scores for low back pain and functional limitations. The Scout trial was conducted under an FDA-approved investigational device exemption protocol to evaluate safety and effectiveness outcomes in instrumented lumbar interbody fusion procedures for treating degenerative disc disease. Spineology […]
Wright Medical loses bid for legal fees in Spineology patent spat
The U.S. Court of Appeals for the Federal Circuit this week shot down an appeal by Wright Medical(NSDQ:WMGI) seeking to obtain legal fees related to a patent infringement case against Spineology which was decided in Wright’s favor this summer. Wright appealed after the U.S. District Court for the District of Minnesota ruled that Wright could […]
Appeals court backs Wright win in Spineology spat
A federal appeals court last week upheld a win for Wright Medical (NSDQ:WMGI) in a patent infringement spat with Spineology over bone reamers. St. Paul, Minn.-based Spineology sued Wright in early 2015, alleging infringement of several claims in a patent covering an expandable reamer designed to cut chambers within bone larger than the external opening into […]
7 medtech stories we missed this week: June 8, 2018
From Royal Philips receiving FDA clearance to NeuroPace launching its epilepsy treatment device, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. FDA clears Philips’s Ingenia Elition 3.0T MR scanner Royal Philips announced in a June 5 press release that it has received FDA 510(k) clearance for its Ingenia […]
Spineology touts 1-year OptiMesh lumbar interbody fusion study results
Spinal tech developer Spineology today released 12-month results from a study of its OptiMesh deployable implant designed for use in instrumented lumbar interbody fusion procedures to treat degenerative disc disease. Results from the Scout trial were presented at the annual meeting of the International Society for the Advancement of Spine Surgery in Toronto, the St. Paul, Minn.-based […]
Spineology raises $5m
Spinal tech developer Spineology said this week it raised $5 million through a convertible debenture, with funds slated to support continued commercialization, product development and clinical research. Money in the round came from Shanghai-based private equity fund Hermed Capital, the St. Paul, Minn.-based company said. “We believe the Spineology investment is a very exciting opportunity. Spineology […]
Spineology wins FDA nod for Rampart One lumbar interbody fusion system
Spinal tech developer Spineology said this week it won FDA clearance for its Rampart One anterior lumbar interbody fusion system. The St. Paul, Minn.-based company said the Rampart One is designed to minimize exposure and vascular retraction requirements associated with traditional anterior spine fusion procedure, and includes both standard and oblique interbody device footprints with integrated […]
Spineology wins expanded FDA clearance for Elite interbody fusion system
Spinal tech developer Spineology said today it won expanded FDA clearance for its Elite expandable interbody fusion system designed for spinal fusion procedures. The Minneapolis, Minn.-based company said it won clerance for a narrower 10mm version of the device, as well as an extended indication allowing the device to be used with allograft bone. “The broader size […]
NASS 2016: Interest grows in surgical robotics for spinal procedures
Mazor Robotics (NSDQ:MZOR) unveiled its next-generation robot-assisted surgery system and Globus Medical (NYSE:GMED) for the 1st time showcased the functional prototype of its Excelsius platform at the NASS 2016 meeting in Boston last week, signifying an increased interest in robotic surgeons among major players. Mazor developed 3 generations of products over 15 years and does 95% of its business in […]
Spineology wins FDA 510(k) for Rampart Duo interbody fusion device
Spinal tech developer Spineology said today it won FDA 510(k) clearance for its Rampart Duo interbody fusion system. The St. Paul, Minn.-based company said its newly-cleared Rampart Duo is the 1st device of its kind to combine PEEK, titanium and graft containment mesh elements. “Rampart Duo is an innovative interbody fusion device that builds upon Spineology’s OptiMesh […]
Spineology makes Musculoskeletal Transplant Foundation its sole allograft supplier
Spinal tech developer Spineology said today that it expanded its relationship with the Muscoloskeletal Transplant Foundation, making it the sole tissue provider for its allograft product lines. The expanded deal makes MTF the sole provider of tissue for Minneapolis-based Spineology’s new Incite cortical fibers bone grafting solution. “MTF has a long track record of delivering safe, […]
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