Scoliosis News
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FDA clears the nView s1 imaging system with integrated navigation
nView medical Inc. (nView) announces the 510(k) clearance of the nView s1 with navigation option by the U.S. Food and Drug Administration (FDA). nView’s mission is to make surgery safer, faster, and consistently accurate by creating instant 3D information throughout the surgical procedure. nView s1 is an imaging system that integrates the latest developments in low-dose X-ray imaging and ...
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Carlsmed and the International Spine Study Group Foundation Announce Long-term Partnership
CARLSBAD, Calif.--(BUSINESS WIRE)--Carlsmed, Inc., a commercial stage medical device technology company, is announcing today that it has partnered with the International Spine Study Group Foundation (ISSGF), the premier study group on adult spinal deformity, to collect data on surgical treatment with personalized interbody devices. Long term outcomes data will be collected to assess the role of ...
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FDA has granted the company a Breakthrough Device Designation for its MIScoli™ system
Spino Modulation Inc., a subsidiary of Spinologics Inc., announced today that the U.S. Food and Drug Administration (FDA) has granted the company a Breakthrough Device Designation for its MIScoli™ system, an innovative vertebral body tethering (VBT) device to treat scoliosis in young adolescents. The FDA Breakthrough Device Program is intended to help patients receive more timely access to ...
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Surgivisio launches pediatric app
Surgivisio today announced the launch of its pediatric application for spine surgery. The French company, which markets the only unified surgical platform combining 2D fluoroscopy, 3D imaging and real-time navigation, now offers its customers a pediatric mode with an additional X-ray optimization for dose reduction. "The development of a pediatric mode that would enable us to reduce the x-ray ...
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