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. […]
Regulatory/Compliance
FDA | Recalls | 510(k) | Pre-Market Approvals | MDSAP | Clinical Trials
ARS Pharmaceuticals wins fast track status for epinephrine nasal spray
ARS Pharmaceuticals said this week that it won fast track status from the FDA for its investigational intranasal epinephrine spray, ARS-1. The San Diego, Calif.-based company’s device is designed to be an easy-to-use treatment for people suffering from severe allergic reactions to food, drugs and insect bites. Get the full story at our sister site, Drug […]
Axonics Modulation touts results of sacral neuromodulation study
Axonics Modulation Technologies (NSDQ:AXNX) announced positive top-line results from a pivotal study of its novel implantable sacral neuromodulation (SNM) devices for the treatment of urinary and bowel dysfunction. The clinical study demonstrated that patients implanted with the Axonics r-SNM system experienced clinically meaningful and statistically significant improvements in urinary urgency incontinence (UUI) symptoms and quality of […]
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 […]
Edwards Lifesciences wins CE Mark for Pascal mitral repair device
Edwards Lifesciences (NYSE:EW) said late yesterday that it won CE Mark approval in the European Union for its Pascal transcatheter valve repair system intended to treat mitral regurgitation. The Pascal system is designed to reduce mitral regurgitation while maintaining native anatomy and features contoured, broad paddles to maximize coaptation of the mitral leaflets and a central […]
AdvaMed president & CEO Scott Whitaker to participate in keynote interview at DeviceTalks Boston 2019
WTWH Media and MassDevice.com announced today that Scott Whitaker, president and CEO of AdvaMed, will be a featured keynote speaker at DeviceTalks Boston 2019. DeviceTalks Boston, which takes place on June 5-6, 2019 at the Seaport World Trade Center, brings together engineering, product development and commercialization professionals to share the challenges and best practices of getting […]
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. […]
Cash-strapped Aradigm declares bankruptcy
Aradigm Corp. (NSDQ:ARDM) announced last week that it’s officially declaring bankruptcy. Strapped for cash, the Calif.-based company resigned to filing for Chapter 11 protection after it couldn’t confirm funding from its primary investor and partner, Grifols. Get the full story at our sister site, Drug Delivery Business News.
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 […]