Medical Devices: Page 107


  • Cardinal Health sells troubled Cordis unit to private equity firm for $1B

    Hellman & Friedman's acquisition of the maker of interventional vascular technology follows Cardinal's 2015 buy of Cordis from Johnson & Johnson for $1.9 billion.

    By March 12, 2021
  • Deep Dive

    Hospitals lift curtain on prices, revealing giant swings for hips, knees and more

    At a Sutter hospital in San Francisco, a joint replacement ranges from $22,865 to $101,571, accordind to a Healthcare Dive analysis of data hospitals are required to report as of January. 

    By Samantha Liss , Nami Sumida • March 11, 2021
  • 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
  • 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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    CMS pushes back kidney care payment model start date to January 2022

    The rule incentivizes delivery of at-home dialysis care with increased payments. Baxter and Outset Medical are among those that pushed for the changes.

    By Rebecca Pifer • March 11, 2021
  • 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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    Docs writing in NEJM push CMS to drop breakthrough payment rule

    Rescinding the rule would stop a change analysts saw as a "significant commercial tailwind" for companies including Abbott, J&J and Medtronic.

    By March 11, 2021
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    GE Healthcare predicts growth, hike in digital investment as pandemic eases

    "We are seeing procedure volumes increasing, contributing to the rebound of our pharmaceutical diagnostics business and we see sequential market growth in imaging and ultrasound," CEO Kieran Murphy said during an investor event.

    By March 11, 2021
  • Vast majority of hospitals say they have an AI strategy, up from just half last year

    AI technologies have also caught the attention of the medical device industry, with top medtechs like Medtronic, GE Healthcare and Philips investing in the space.

    By Rebecca Pifer • March 10, 2021
  • EU remote audits under MDR in doubt as divergent national positions persist

    Team-NB pulled a proposal unveiled in February amid sustained resistance. A Commission medical device group met last week but has yet to disclose a solution.

    By March 10, 2021
  • Intersect touts CMS coverage changes as boon for patient, physician access

    The agency published an average selling price for Intersect's corticosteroid-eluting sinus implant treatment for nasal polyps, which "should help clarify payment and ease payor coverage adjudication," SVB Leerink analysts wrote.

    By March 9, 2021
  • Abbott Laboratories
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    Courtesy of Abbott
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    Abbott capitalizes on digital health boom with virtual clinic for neuromodulation therapy

    The FDA-approved virtual clinic is the medtech giant's next step to gain share in the neurmod market from rivals Medtronic, Boston Scientific and Nevro.

    By March 9, 2021
  • Colfax to split in 2, creating over $1B orthopaedic player

    The split will create a medtech company with a portfolio of orthopaedic devices forecast to generate sales of around $1.4 billion this year. The move is expected to facilitate more M&A.

    By March 8, 2021
  • Backing for telehealth Medicare reimbursement gains steam in Congress

    Tuesday's House committee mirrored similar Senate panels. There's bipartisan support for a permanent expansion to a greater share of the population, but legislators are split on what form it should take. 

    By Rebecca Pifer • March 5, 2021
  • Insulin pump adoption seen climbing 21% in 2021 on wearables boom: survey

    The SVB Leerink poll of 101 endocrinologists and nurse practitioners also projects a shift in market position among top players like Medtronic, Insulet and Tandem Diabetes Care.

    By March 5, 2021
  • Warchests, distressed assets drive medtech M&A flurry early in 2021

    The industry is averaging more than one $100 million-plus takeover a week, as the influx of COVID-19 test revenues and pressures on companies reliant on surgical procedures create buying opportunities.

    By March 5, 2021
  • 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 clamps down on bogus device 'registration certificates' amid rising use during pandemic

    The agency sent letters to 25 companies after identifying a boost in use of materials "deceptively indicating" it had assessed medical devices.

    By March 4, 2021
  • Boston Scientific puts up $1B in cash to buy Lumenis surgical line from private equity

    Wall Street analysts generally applauded the deal, which will see the medtech leader acquiring a portfolio of laser systems with potential to reach fast-growing markets like China.  

    By Updated March 4, 2021
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    Jacob Bell
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    FDA breakthrough roundup: Cook Medical is latest in round of cardio-themed nods

    The company, among a slew of recent designations granting enhanced feedback and speedier review, plans to file to run a pivotal trial of its Zenith Fenestrated+ Endovascular Graft this year.

    By March 3, 2021
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    Medtronic
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    Medtronic's HeartWare receives another Class I recall after more patient deaths

    The medical device giant is recalling 157 HVAD Pump Implant Kits from the U.S. after receiving complaints that some devices failed to start or restart promptly.

    By March 2, 2021
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    Hillrom steps back from $375M BardyDx deal on reimbursement setback

    The hospital products maker said a Medicare contractor's unexpected drop in payment rates for BardyDx's cardiac monitoring technology meant closing conditions for the transaction had not been satisfied.

    By March 1, 2021
  • FDA OKs device to avert traumatic brain injury during sports

    Approval was based in part on a study of 284 U.S. high school football players, suggesting the neck-worn product can minimize "slosh" in the brain that occurs in unprotected athletes who suffer head impacts.

    By March 1, 2021
  • iRhythm Zio XT
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    Permission granted by iRhythm Technologies
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    iRhythm still faces reimbursement uncertainty after meetings with Medicare rate negotiator

    CEO Michael Coyle said the cardiac monitoring company and other industry representatives met with a Medicare Administrative Contractor twice, but added that there are no assurances rates will come up.

    By Feb. 26, 2021
  • NuVasive buys Simplify Medical in play for $2.6B cervical spine market

    The $150 million acquisition will add to the pandemic-related challenges for NuVasive in 2021, with investments to train surgeons and run clinical trials offsetting the low anticipated sales this year.

    By Feb. 26, 2021
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    Axonics adds incontinence device to portfolio in $200M Contura takeover

    The targeted prescribers of Contura's urethral bulking agent are the same physicians who use Axonics' implantable sacral neuromodulation to treat urinary disorders. Analysts said the business logic seems sound.

    By Feb. 26, 2021
  • Diabetes wearables look resilient through 2021, bucking broad medtech trends

    Dexcom, Tandem and Insulet pointed to targeting Type 2 patients and DTC as growth drivers in posting year-end results. One analyst gushed that "the golden age of diabetes care is still here."

    By Feb. 25, 2021
  • Nevro predicts resurgent pain implant sales in 2021 after slow start to the year

    William Blair analysts said market growth is likely to remain challenging in the short run as CEO Keith Grossman argued the company was not losing share to rivals, which include Medtronic and Abbott.

    By Feb. 25, 2021
  • UK adopts medical device legislation, setting stage for new databases and sanctions

    Politicians framed the new law as furthering efforts to fix failings that delayed regulatory responses to safety problems with products including pelvic mesh.

    By Feb. 24, 2021