Life Spine’s ARx sacral alar iliac spinal fixation system earned expanded 510(k) clearance from the FDA, according to an April 28 news release. The system is now approved for use with compatible pedicle screws with 5.5mm or 6.0mm posterior rods…
Spinal Tech
Medical device company Medtronic has experienced a cybersecurity incident, with hackers breaching its network, according to an April 28 report from The HIPAA Journal. The hackers only gained access to a limited portion of Medtronic’s network, and the attack was…
Amplio Spine signed a letter of intent to acquire the KeyLift expandable inter laminar stabilization system, according to an April 23 news release. The acquisition includes KeyLiftXS and KeyLift XL, four sizes for eight total SKUs and related assets from…
Spinal Simplicity earned the FDA’s 510(k) clearance for the Freedom decompression system, according to an April 23 news release. The minimally invasive system is designed for lumbar spinal stenosis and introduces enhanced instrumentation to improve procedural precision and efficiency. “Freedom…
Foundation Surgical’s NavLock lateral lumbar disc prep instruments earned the FDA’s 510(k) clearance for use with Medtronic’s O-arm and StealthStation, according to an April 16 LinkedIn post. The NavLock system offers real-time navigation for every step of discectomy, and Foundation…
CarboFix’s CarboClear hybrid posterior screw system earned 510(k) clearance from the FDA. The system is cleared for use across indications including oncology, degenerative conditions, trauma, revision surgery and infections, according to an April 14 news release shared with Becker’s. It…
Aclarion earned a U.S. patent supporting its AI spine diagnostic tool, according to an April 16 news release. U.S. Patent #12,601,803, is titled “System for Machine Learning-Based Model Training and Prediction for Evaluation of Pain” and covers the company’s machine…
SurGenTec’s TiLink_L navigational instruments earned the FDA’s 510(k) clearance, according to an April 15 news release. The TiLink-L navigation instruments are designed to use with the TiLink SI joint fusion system. They’re also compatible with Medtronic’s StealthStation platform. “The TiLink…
VB Spine completed its acquisition of Augmedics’ xvision spine system, according to an April 13 news release. The deal was first announced in February and is expected to poise VB Spine to become a leader in AR-enabled spine tech. “We…
BoxSpine earned FDA clearance for its Duet spinal fixation system, according to an Aug. 9 news release. Duet is a three-piece stabilization system designed to eliminate the need for traditional rods. The design has a halo device that captures a…
