Medical Devices: Page 180


  • Stryker buys spine device maker K2M for $1.4B

    The acquisition is expected to give Stryker some needed heft in the category, adding several differentiated products in faster-growth areas of the specialty.

    By Aug. 31, 2018
  • Medtronic cryoballoon reduces persistent afib symptoms in study

    The ablation device uses cold energy to interrupt irregular electrical signals in the heart in a minimally invasive procedure.

    By Aug. 31, 2018
  • the FDA Headquarters Explore the Trendline
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    Trendline

    Top 5 stories from MedTech Dive

    From haphazard layoffs at the Food and Drug Administration to the industry’s current IPO environment and tracking FDA-authorized AI devices, here is a collection of top stories from MedTech Dive.

    By MedTech Dive staff
  • Philips licenses Air Force mobile patient monitoring technology

    The Andover, Massachusetts-based medtech giant plans to leverage the wearable system for telemedicine purposes.

    By Meg Bryant • Aug. 31, 2018
  • Alcon withdraws glaucoma device amid long-term safety concerns

    Five-year data linked the stent to increased endothelial cell loss.

    By Aug. 30, 2018
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    Credit: Andrew Propp, FDA / Edited by BioPharma Dive
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    Gottlieb hails early breakthrough device successes, plans AI benchmarks

    The commissioner set out how the FDA is accelerating the development of medical devices.

    By Aug. 30, 2018
  • SynCardia stands behind its artificial heart driver

    The Companion 2 driver that supports SynCardia's temporary Total Artificial Heart has not been identified as the root cause of increased mortality and stroke rates in a post-approval study, the company told clinical partners.

    By Aug. 29, 2018
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    Balloons as effective as stents to open small arteries, study says

    ​The study is the largest randomized trial to look at whether drug-coated balloons are as effective as drug-eluting stents, according to the researchers.

    By Aug. 29, 2018
  • NIH-backed trial links device to drop in cardiac arrest deaths

    The study found patients were more likely to survive after treatment with laryngeal tubes.

    By Aug. 29, 2018
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    FDA warns Zimmer Biomet about quality violations at Indiana plant

    The former Zimmer Holdings has struggled to integrate Biomet since acquiring its cross-town rival for $13 billion in 2015.

    By Aug. 28, 2018
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    Wright Medical inks $435M takeover of implant firm Cartiva

    An arthritis implant with fast-growing sales is the focal point of the acquisition.

    By Aug. 28, 2018
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    DexCom acquires maker of insulin dosing algorithm

    The company expects the first commercial launch of an automated insulin delivery system using TypeZero's inControl algorithm in 2019.

    By Aug. 27, 2018
  • Patients getting needed supplies under DME bidding: GAO

    The GAO found that the number of durable equipment suppliers decreased 8% in 2016, consistent with the years before the rate adjustments went into effect.

    By Aug. 27, 2018
  • Hands-free device may track astronauts' vital signs in space

    The camera analyzes pulsations in the blood vessels of a person's face to track heart beats and respiration rates.

    By Aug. 27, 2018
  • Robotic surgery market is about to get crowded, report says

    GlobalData predicts larger companies will accelerate investment in surgical robotics through acquisitions and partnerships.

    By Aug. 24, 2018
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    How TraceLink will use $93M in new funds to showcase the benefits of serialization

    The data network plans to expand into a life sciences software suite to help pharmaceutical supply chains tap into data that was unavailable prior to track-and-trace regulations.

    By Edwin Lopez • Aug. 23, 2018
  • FDA posts guidance on endpoints in osteoarthritis trials

    The draft guide says more research is needed before the agency accepts structural endpoints.

    By Aug. 23, 2018
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    Jacob Bell
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    Gynesonics gets FDA nod for fibroid ablation device

    The minimally-invasive device uses radiofrequency to reduce the volume of uterine fibroids.

    By Aug. 23, 2018
  • NIST offers guide to securing wireless infusion pumps

    Several companies worked with the agency to develop the guide, including B. Braun Medical, Baxter, Becton Dickinson and Cisco.

    By Aug. 22, 2018
  • FDA extends EpiPen expiration date to ease shortages

    Current supply issues stemming from ongoing manufacturing delays could put children at risk as the school year approaches.

    By Suzanne Elvidge • Aug. 22, 2018
  • Medicare overpaid millions for outpatient planning services

    A report from the HHS Office of Inspector General blamed the excessive payments for intensity-modulated radiation therapy planning services mostly on hospitals not knowing or misinterpreting CMS guidance.

    By Les Masterson • Aug. 21, 2018
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    Diabetes, heart device sales drive strong Medtronic Q1

    Demand for the artificial pancreas, the world's first device that monitors blood glucose and administers insulin, led growth in the diabetes business.

    By Aug. 21, 2018
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    Doctors often fail to list conflicts in device studies: JAMA report

    Doctors got the highest payouts from Medtronic, which accounted for more than $187.4 million, followed by Stryker and Intuitive Surgical, according to a JAMA analysis.

    By Aug. 20, 2018
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    Noninvasive magnetic stimulation for OCD wins FDA nod

    The agency's clearance for OCD is an extension of a 2008 approval of transcranial magnetic stimulation to treat major depression.

    By Aug. 20, 2018
  • FDA finds higher death, stroke rates for latest SynCardia artificial heart driver

    The agency said it will work with SynCardia to ensure product labeling addresses the post-approval findings.

    By Aug. 20, 2018
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    Novo Nordisk
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    In pursuit of new insulins, Novo may drop more than $800M on Ziylo

    Pricing pressures and competition have pushed diabetes drugmakers to innovate. Novo's looking to do just that in buying the University of Bristol spinout and its glucose-binding molecules.

    By Jacob Bell • Aug. 17, 2018