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 […]
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 […]
Medtronic: Patient deaths left out of paclitaxel-coated balloon analysis
Medtronic (NYSE:MDT) said last week that it inadvertently omitted an undisclosed number of patient deaths from recent studies of its paclitaxel-coated balloons. The company noted that the mistake ultimately does not affect the conclusion that there was no statistically significant difference in all-cause mortality between its In.Pact Admiral drug-coated balloon and plain balloon angioplasty at five years. Get […]
Medtronic wins FDA’s breakthrough status for closed-loop insulin system
Medtronic (NYSE:MDT) said today that it won breakthrough status from the FDA for its investigational personalized closed-loop insulin pump system. The company touted its technology as enabling automated insulin delivery in a real-time, adaptable and personalized fashion. Get the full story at our sister site, Drug Delivery Business News.
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