ViewRay (NSDQ:VRAY) said yesterday that it won FDA 510(k) clearance to offer soft tissue visualization capabilities with its MRIdian system. The newly cleared features include expanded high-definition visualization and contrast between tissues, diffusion weighted imaging for improved distinguishing between normal and tumor tissues and more detailed, brighter and faster anatomical planar imaging, the Cleveland-based company said. […]
510(k)
Philips wins FDA nod for DigitalDiagnost C90 digital radiography system
Philips (NYSE:PHG) said yesterday that it won FDA 510(k) clearance for its DigitalDiagnost C90 digital radiography system. The Amsterdam-based company said that the DigitalDiagnost C90 includes a live camera image displayed directly at the tube head to provide a clear view of the anatomical area being scanned during positioning. The newly cleared system also incorporates Philips […]
Hygieia wins FDA clearance for insulin management app
Hygieia said today that it won 510(k) clearance from the FDA for its insulin management app designed to optimize insulin dosing among people with Type 2 diabetes. The Michigan-based company touted its product as the first insulin management mobile app that can titrate individualized doses for all types of insulin regimens. Get the full story at […]
Intuitive Surgical wins FDA clearance for robotic-assisted lung biopsy system
Intuitive Surgical (NSDQ:ISRG) said today that FDA has cleared its Ion system — a robotic-assisted, catheter-based platform meant to enable minimally invasive biopsy deep within the lung. Sunnyvale, Calif.–based Intuitive plans to start selling the Ion system in the U.S. in a measured fashion; it’ll start shipping to customers in coming months. The Ion system includes an […]
NuVasive wins FDA, CE Mark for Precice internal bone transport system
NuVasive Inc. (NSDQ:NUVA) said today that it won FDA 510(k) clearance and CE Mark clearance in the European Union for its Precice bone transport system. The San Diego, Calif.-based company touted the system as the only all-internal system indicated for use in segmental bone loss treatment in the tibia and femur resulting from trauma or infection. […]
ReWalk Robotics files for exoskeleton suit clearance
ReWalk Robotics (NSDQ:RWLK) said it has applied to FDA for 510(k) clearance of its ReStore exoskeleton suit for gait training during stroke rehabilitation. The Yokneam, Israel-based company designed its exo-suit to provide coordinated plantarflexion and dorsiflexion assistance to a patient’s foot and ankle. It recently won insurer reimbursement from Cigna and completed a clinical trial […]
Bausch + Lomb wins FDA 510(k) for contact lens coating
Bausch + Lomb said today that it won FDA 510(k) clearance for the use of Tangible Hydra-PEG contact lens coating on new devices, now cleared for use with lenses made from its Boston gas permeable materials. The new clearance will allow the Bridgewater, N.J.-based company to use the coating on its Boston XO, Boston XO2, […]
Becton Dickinson wins FDA 510(k) for Wavelinq 4F endoAVF system
Becton Dickinson (NYSE:BDX) said today that it won FDA 510(k) clearance for its WavelinQ 4 French endovascular arteriovenous fistula creation system. The Franklin Lakes, N.J.-based company said that the newly cleared WavelinQ 4F endoAVF system features improved technology that allows for the creation of an AVF in either the ulnar artery and ulnar vein or the radial […]
Zimmer Biomet wins FDA nod for Rosa Knee robotic surgical system
Zimmer Biomet (NYSE:ZBH) said today that it won FDA 510(k) clearance for its Rosa Knee robotically-assisted total knee replacement surgery platform. The newly cleared Rosa Knee system includes 3D pre-operative planning tools and real-time intraoperative data on soft tissue and bone anatomy to improve bone cut accuracy and range of motion gap analysis, the Warsaw, Ind.-based […]
BD launches second-gen ergonomic injection pen
Becton Dickinson & Co. (NYSE:BDX) said this week that its second-generation BD Nano pen needle won 510(k) clearance from the FDA. The company’s needles are designed to provide a more reliable subcutaneous injection depth, according to BD. Get the full story at our sister site, Drug Delivery Business News.
FDA clears Rebound Therapeutics’ minimally invasive neurosurgical endoscope
Rebound Therapeutics has secured FDA 510(k) clearance for its Aurora Surgiscope system, which it touts as the first single-use disposable neurosurgical endoscope. The Aurora system enables minimally invasive access, visualization and illumination during neurosurgical procedures, the Irvine, Calif.–based company said yesterday. “Our physician advisors specified that we enable the complete neurosurgical procedure, without reliance on any […]