Posts filed under: Spine
Vivex is a company based out of Atlanta, Georgia, that specializes in regenerative medicine. Vivex has developed the VIA Disc, an innovative injectable treatment for degenerative disc disease. The first major clinical study regarding this treatment was conducted recently, with...
The FDA has granted 510(k) clearance for the Osteo3 ZP Putty from Sirakoss Ltd. Sirakoss is based out of Aberdeen, Scotland, and originated from research conducted out of the University of Aberdeen. Sirakoss produces nanosynthetic bone regeneration products, providing an...
From the onset of COVID-19, changes were made to various facets of healthcare systems, including the Spine Surgery industry. Many of these changes were adopted in a reactionary manner, in order to protect those at risk. However, it has become...
Augmedics, a company based out of Chicago, gained FDA approval for the sale of its XVision Spine System in the U.S. in December 2019. Now, this technology has been used for its first spine surgery in the U.S. Using the...
Zebra Medical Vision, based in Israel, has recently been granted FDA 510(k) approval for its artificial intelligence product that detects vertebral compression fractures. There currently exists a major problem with under-detection and under-reporting of vertebral compression fractures. Zebra Medical Vision...
Nevro Corp., a medical device company located in Redwood City, California, has earned a CE mark for its product the Senza Omnia, which provides spinal cord stimulation (SCS) for pain relief. Existing research suggests that SCS generally provides positive outcomes...
NuVasive recalls scoliosis treatment devices NuVasive voluntarily issued an Urgent Field Safety Notice (FSN) last month recalling the MAGEC System Model X. The magnetically controlled growing rod devices, designed to brace the spine during growth and minimize the progression of...
Medicrea’s Patient-matched Interbody Cages FDA ApprovedMedicrea has announced FDA clearance for their UNiD® IB3D Patient-Matched interbody cages which will be added to their UNiD® Adaptive Spine Intelligence (ASI) platform. The 3D-printed titanium implant is the first of its kind to offer...
Abbott‘s Low-Dose Neuromodulation Implant for Chronic Pain, Proclaim XR, was recently featured at 2020 International CES. Proclaim XR can connect to Apple products via Bluetooth and to enables patients to have more control over their treatment to regulate their pain...
Augmedics as announced that is has gained FDA 510(k) clearance for XVision Spine in the U.S. XVision Spine is an augmented reality (AR) surgical guidance system that helps surgeons better visualize the patient’s spinal anatomy. XVision projects critical navigation data...
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