Becton Dickinson & Co. (NYSE:BDX) subsidiary CareFusion said today it won FDA 510(k) clearances for 2 sizes of vertebral balloon systems designed for spinal augmentations. The company received clearance from the FDA for its 13-gauge AVAmax and 11-gauge AVAflex vertebral balloon systems for treating vertebral compression fractures. “We are committed to investing in research and development […]
Spine
Stimwave wins FDA 510(k) for SCS device
Stimwave Technologies said it won FDA 510(k) clearance for its Stimwave Freedom-8A 8-electrode wireless neuromodulation spinal cord stimulation device for relieving chronic back and leg pain. The Fort Lauderdale, Fla.-based company said it is the 1st wireless, fully programmable SCS neuromodulation device available. Stimwave said it has begun commercialization of the device and began implantation […]
FDA: InVivo spinal scaffold trial cleared from pilot to pivotal
InVivo Therapeutics (NSDQ:NVIV) said today it won conditional approval to convert its ongoing Neuro-Spinal scaffold pilot study to a pivotal probable benefit study, allowing the company a faster path to FDA approval. The conditional approval is based upon a change to the informed consent form the company already submitted to the FDA, and full approval is […]
InVivo looks to blaze ‘Bioengineered Neural Trails’ in spinal cord injury treatment
InVivo Therapeutics (NSDQ:NVIV) said today it is looking to ‘Bioengineered Neural Trails’, injectable biomaterial and neural stem mixtures, to help treat chronic spinal cord injuries. The Cambridge, Mass.-based company said it will focus its research efforts on the new therapy, and has inked agreements with the University of California, UC San Diego and Dr. James Guest […]
Greatbatch wins FDA PMA for Algovita SCS
Greatbatch (NYSE:GB) said yesterday it won FDA premarket approval for its Algovita spinal cord stimulation system for treating chronic intractable pain. The Algovita system is a rechargeable, 24-electrode spinal cord stimulation system designed to deliver electrical pulses to the dorsal column of the spinal cord to treat intractable chronic pain of the trunk or limbs, the Frisco, […]
St. Jude Medical’s Proclaim Elite debuts in Europe
St. Jude Medical (NYSE:STJ) said today that it’s launching its Proclaim Elite spinal cord stimulation device in the European Union after winning CE Mark approval there, including an indication for conditional MR labeling for the Proclaim Elite for head and extremity scans. The approval also covers St. Jude’s “burst stimulation” technology, which is designed to reduce the sensation of […]
Medtronic wins FDA panel date for DIAM spine stabilization system
Medtronic (NYSE:MDT) won a date with an FDA advisory panel for its DIAM spinal stabilization system. The federal safety watchdog’s Orthopaedic & Rehabilitation Devices panel is slated to meet Feb. 19, 2016, to consider the pre-market approval application for the DIAM system, the FDA said today. DIAM stands for “device for intervertebral assisted motion.” The DIAM system is designed […]
St. Jude Medical wins FDA approval for Proclaim Elite spinal cord stim device
St. Jude Medical (NYSE:STJ) said today that it won FDA approval for its Proclaim Elite spinal cord stimulation device for treating chronic pain. Little Canada, Minn.-based St. Jude claimed the device as the sole U.S.-approved upgradable and recharge-free SCS system, noting that the federal safety watchdog also approved conditional MR labeling for the Proclaim Elite for head and […]
Zyga closes $20m round
Zyga Technology said yesterday it closed a $20 million round of financing, bringing $15 million in debt supplemented by $5 million in equity. Based in Minnetonka, Minn., Zyga develops minimally invasive surgical products for the treatment of lumbar spinal conditions. Funds from the round are slated to support sales and commercialization of its minimally invasive […]
Globus Medical targets robotics market, $1B in sales
Globus Medical (NYSE:GMED) said last week that it’s planning to derive “significant revenue” from its robotics program in 2017 and wants to cross the $1 billion sales mark by 2020. At its 1st-ever investor day Nov. 12, Audubon, Pa.-based Globus said it expects to post earnings per share of $1.07 on sales of $539 million. The […]
Can Greg Lucier bring the Life Technologies mojo to NuVasive?
Newly minted NuVasive CEO Greg Lucier has quite the pedigree when it comes to building successful companies. Lucier, who was named permanent CEO of the San Diego, Calif.-based spinal device company in May 2015, built Life Technologies from a start up (then named Invitrogen) to a global biotech juggernaut with 12,000 employees and just under […]