Precision Spine has launched its Reform Ti Modular Pedicle Screw System globally. The system is designed to provide surgeons increased flexibility, versatility and visibility to meet different requirements of degenerative and trauma procedures. Reform Ti Modular Pedicle Screw System features titanium tulips that are available in standard and reduction options that offer an audible click […]
Precision Spine launches posterior cervical stabilization device
Precision Spine today said it has launched its Reform Posterior Occipital Cervical Thoracic System in the U.S. The Reform POCT System is a posterior spinal fixation system that enables stability in the occupy, cervical and thoracic spine during spine fusion. The system is so far indicated for DDD, spondylolisthesis, spinal stenosis, trauma (fracture or dislocation), […]
7 medtech stories we missed: Feb. 3, 2017
From disappointing Getinge earnings to a $2.25 billion U.S. Defense Department contract for Cardinal Health to a host of 510(k) clearances, here are seven recent medtech stories that are still worth a mention. 1. Getinge disappoints on earnings—again Getinge stock took a nearly 10% tumble last week after releasing earnings that Reuters says lagged analyst […]
Precision Spine wins FDA 510(k) for AccuFit lateral plate system
Precision Spine said today it won FDA 510(k) clearance for its AccuFit lateral plating system designed to treat spinal instability. The Parsippany, N.J.-based company’s AccuFit lateral plate system consists of non-sterile, single use rigid plates designed to attach to the lateral portions of the vertebral body of the thoracolumbar spine with bone screws. “As a system that […]
Novadaq co-founder Mangat tapped for CEO | Personnel Moves July 8, 2016
Novadaq co-founder Mangat tapped for CEO Novadaq Technologies (TSE:NDQ) said Wednesday that it tapped co-founder and co-inventor of the company’s SPY imaging technology Rick Mangat as its new president and CEO, taking over for Arun Menawat who has resigned to pursue other opportunities. Mangat previously served as senior veep and general manager at Novadaq. “I […]
Precision Spine wins 510(k) for pedicle screw
Precision Spine said today it won FDA 510(k) clearance for its reform modular and hydroxyapatite coated pedicle screw systems. The modular screw system is designed with a cobalt chrome tulip and proximal tapered triple lead thread designed to enhance pull-out strength and increase visibility, the Parsippany, N.J.-based company said “The Reform system is one of the […]
FDA clear Precision Spine’s next-gen minimally invasive spinal surgery tools
The FDA cleared Precision Spine’s Mini-Max system, a minimally invasive access device designed to help spine surgeons achieve the same or better results than so-called "gold standard" open surgical procedures.
The system features the existing minimally invasive surgery techniques, but aims to shorten physicians’ learning curves and reduce operating time, according to the press release.
FDA news: Covidien, Preventice, Precision Spine win FDA clearances
A trio of medical device companies won nods from the FDA’s Center for Devices & Radiological Health this week, including a surgical sealer, a wireless cardiac monitor and a spinal plating system
Covidien (NYSE:COV) said it won 510(k) clearance from the FDA for its LigaSure surgical sealer/divider for ear, nose and throat procedures.
