Medical Devices: Page 117


  • Abbott Libre Sense Glucose Sport Biosensor
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    Courtesy of Abbott
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    Dexcom takes another step to keep CGMs in hospitals while Abbott targets athletes

    By amassing early evidence in untapped populations, the companies hope to pursue lucrative new parts of the U.S. market.

    By Maria Rachal • Sept. 18, 2020
  • Trump admin unveils final kidney care payment model

    The CMS policy seeks to incentivize more at-home dialysis treatment, which could have implications for device makers including Baxter and newly public Outset Medical.

    By Samantha Liss • Sept. 18, 2020
  • the FDA Headquarters Explore the Trendline
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    Sara Silbiger via Getty Images
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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
  • A picture of the exterior of the US Department of Health and Human Services. In front of the building is a black sign designating the building's name.
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    Alex Wong via Getty Images
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    Nixed Philips, Hamilton, Vyaire ventilator contracts subject of expanding House probe

    The oversight subcommittee wants to know if the HHS cancellation of "wasteful" contracts with the three medtechs included generous termination settlements involving payoffs to the companies. 

    By Sept. 17, 2020
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    Getty Images
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    Moody's raises medtech outlook amid testing boom at Abbott, Thermo Fisher

    But the investors service warned the pace of innovation in the COVID-19 test sector may render some products obsolete and create winners and losers.

    By Sept. 17, 2020
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    Adobe Stock
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    Intersect ENT strikes €60 Fiagon buyout to expand in balloon sinuplasty

    The takeover of the German electromagnetic surgical navigation specialist comes two months after a report that Medtronic moved to acquire Intersect.

    By Sept. 16, 2020
  • Medtronic, Stryker among CEOs weighing in on COVID-19 recovery

    Execs at Boston Scientific and Edwards also presented at the Morgan Stanley Global Healthcare Conference this week, casting optimism on a year-end return to growth after springtime lows.

    By Maria Rachal , Sept. 15, 2020
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    Jacob Bell
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    FDA finalizes voluntary consensus standard guidance

    The final guidance offers updated advice for submitting requests for recognition in the premarket review process and explains when the agency may withdraw a previously recognized standard.

    By Sept. 15, 2020
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    FDA
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    Another BD Alaris recall pegged Class I event by FDA

    It's the latest in a flurry of notifications about the infusion pump line of products, which have been the subject of 18 of the high-risk recall notices since March.

    By Sept. 15, 2020
  • Abbott, Illumina, other medtechs shape guide conveying device risks to patients

    The report from the public-private Medical Device Innovation Consortium is part of a larger movement by FDA to integrate the patient's voice in areas that include device design, clinical development and regulatory review.

    By Sept. 14, 2020
  • Fitbit sense watch at launch event
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    Courtesy of Fitbit
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    Fitbit wins FDA clearance for EKG app

    The nod brings the wearables giant up to speed with Apple and Samsung in the heart rhythm tracking arena.

    By Rebecca Pifer • Sept. 14, 2020
  • The FDA logo on a glass pane at the agency's campus in Silver Spring, Maryland.
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    Jacob Bell/MedTech Dive
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    FDA AI-machine learning strategy remains work in progress

    Nearly 18 months since the agency's discussion paper on a proposed regulatory framework, critical pieces are still needed for the development of draft guidance, agency digital health chief Bakul Patel said. 

    By Sept. 14, 2020
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    FDA
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    FDA advisers support down-classing bone growth stimulators, in face of industry and lawmaker pushback

    But the orthopaedic devices panelists said there should be rigorous clinical evidence standards for the class of products currently sold by Orthofix, Zimmer Biomet, Bioventus and DJO, which are yet to be defined.

    By Maria Rachal • Sept. 11, 2020
  • Thermo Fisher hikes growth forecast, expects COVID-19 sales to top $3B in late 2020

    The company forecasts significantly higher growth this year than it's posted in the past, despite suffering a slow first quarter due to early disruption from the pandemic.

    By Sept. 11, 2020
  • The FDA logo on a glass pane at the agency's campus in Silver Spring, Maryland.
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    Jacob Bell/MedTech Dive
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    FDA aims to harmonize adverse event reporting with eMDR updates, makes patient problem codes public

    The agency finalized adding new elements and fields to its Electronic Medical Device Reporting system, and also clarified protocols for manufacturers with EUAs or following COVID-19 enforcement policies.

    By Sept. 10, 2020
  • The best TAVR device? Experts opine on when to use Boston Scientific, Edwards or Medtronic valve

    A JAMA Cardiology review found design differences may give each transcatheter aortic valve replacement device small competitive advantages in certain circumstances.

    By Sept. 10, 2020
  • Medtronic tricuspid valve replacement device wins FDA breakthrough status

    Although the medtech's Intrepid device is just starting an early feasibility study, it may ultimately go up against transcatheter tricuspid valve repair options from Abbott and Edwards.

    By Maria Rachal • Sept. 9, 2020
  • Ultrasound ablation provided 'adequate' short-term control for prostate cancer patients, small study shows

    Only 9% of men treated with products from SonaCare or EDAP TMS required surgery or radiation over the next two years, but larger studies are needed to better show how well HIFU works, a Journal of Urology publication concluded.

    By Sept. 9, 2020
  • Ortho device reclassifications, MDUFA reauthorization among FDA's fall meeting lineup

    The agency's upcoming slate of virtual medtech meetings kicks off Tuesday with an orthopaedic devices panel that will consider a proposal to downclassify noninvasive bone growth stimulators.

    By Sept. 8, 2020
  • Surgeries keep rising, buoying Wall Street's year-end medtech outlook

    Jefferies reported a fourth consecutive week of growing hospital traffic, while Bank of America is "broadly bullish" on the medical devices sector as 2020 wraps up.

    By Sept. 8, 2020
  • Edwards gets FDA approval for Sapien 3 in new patient population

    The PMA expands the transcatheter valve for use in congenital heart defect patients who suffer problems following surgical repair, positioning the device to compete against a range of treatment options.

    By Sept. 8, 2020
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    Dollar Photo Club
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    Abbott resurrects resorbable scaffold tech for below-the-knee trial

    The medtech previously stopped selling the technology amid evidence it increased the risk of major adverse cardiac events, but recent data has revealed a new BTK opportunity.

    By Sept. 4, 2020
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    Jacob Bell
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    FDA flags 428 spinal cord stimulator patient deaths, urges more tests before implant

    The agency revealed the figures in a letter to healthcare providers urging simulations prior to permanently implanting the devices, sold by companies such as Abbott, Boston Scientific, Medtronic and Nevro.

    By Sept. 4, 2020
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    Watchdog gives high marks to CMS competitive bidding program

    The Office of Inspector General probe found the agency followed procedures 97% of the time when awarding contracts for durable medical equipment, prosthetics, orthotics and supplies.

    By Sept. 3, 2020
  • Boston Scientific, Stryker win CMS new tech add-on pay, BD left out

    When combining eligible devices with other recipients, including drug therapies, the agency estimates spending on the payments will total roughly $874 million, a 120% year-over-year increase. 

    By Maria Rachal • Sept. 2, 2020
  • Stryker reaches agreement with Colfax for Wright Medical deal divestitures

    The medtech disclosed Thursday the orthopaedics competitor's DJO Global subsidiary agreed to acquire its ankle and finger joint replacement businesses to shore up U.S. and U.K. antitrust concerns.

    By Maria Rachal • Updated Oct. 16, 2020