Medical Devices: Page 125


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    Zimmer posts $509M loss in Q1 as 80% of business faces COVID-19 hit

    Like rivals, the medtech expects Q2 to bear the brunt of deferred procedures. But the pace of expected recovery thereafter is fluid and does not assume significant recurrence of the virus later this year, execs noted.

    By Maria Rachal • May 11, 2020
  • AtriCure treatment for persistent AFib shows superiority in study

    The ablation procedure met study goals among patients with hard-to-treat forms of the heart rhythm disorder, which analysts say put it on track for FDA approval to address a market worth at least $1 billion.

    By May 11, 2020
  • 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
  • Transmission electron microscopic image of an isolate from the first U.S. case of COVID-19, formerly known as 2019-nCoV. The spherical viral particles, colorized blue, contain cross-section through th
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    Courtesy of Centers for Disease Control and Prevention
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    Roundup: Q1 medtech reports give glimpse into coronavirus-era gains and losses

    Much of the sector may be considered recession-proof — but it's not social distancing-proof. The last weeks of March previewed the dramatic trajectory of drops in routine testing and a mounting backlog of elective procedures.

    By Maria Rachal • May 7, 2020
  • BD says surgery revenues fell as much as 70% in April

    As it faces pandemic headwinds, BD is also continuing to deal with problems with its Alaris infusion pump system and modules and expects to record a $200 million charge related to remediation efforts.

    By May 7, 2020
  • The FDA logo on a glass pane at the agency's campus in Silver Spring, Maryland.
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    FDA details COVID-19 era reporting rules to stymie medical device shortages

    Under new powers granted by the CARES Act for the duration of the health crisis, the guidance to industry lays out when and how to notify the agency about changes that could affect product availability.

    By May 7, 2020
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    Canceled surgeries drive hospitals to estimate $200B in losses in early months of coronavirus

    The American Hospital Association's approximation counts the first four months of the pandemic, including a forecast through June. It comes as the lobby pushes for more aid on top of the $175 billion Congress has allocated so far.

    By Ron Shinkman • May 6, 2020
  • Notified bodies saw CE marks spike in 2019 ahead of now-delayed MDR

    Team-NB attributed the surge to an industry push to get certified under the outgoing Medical Device Directive, before the COVID-19 pandemic led the EU to postpone the new regulations start date by a year.

    By May 6, 2020
  • Deferred elective procedures wipe out Smith & Nephew revenues, prompting $200M in cost cuts

    The medtech's sales were nearly halved in April due to the pandemic, with its orthopaedics, sports medicine and wound management lines all experiencing drops in demand. The company is “not reducing headcount at this stage."

    By May 6, 2020
  • Oncology systems maker Varian ekes out sales gain amid procedure delays

    The company managed a 2% uptick in Q2 revenues despite the slowdown in non-essential procedures as people postponed routine screenings, which in turn has delayed the start of treatment for new cancer patients.

    By May 5, 2020
  • AHA, societies share new roadmap amid restarts to TAVR, other postponed procedures

    As more U.S. states ease coronavirus-driven restrictions on elective medical care, North American cardiovascular groups laid out stages of safe reintroduction for invasive procedures and diagnostic imaging.

    By May 5, 2020
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    Respiratory muscle stimulator greenlighted by FDA for COVID-19 patients

    In an attempt to more quickly free up sought-after ventilators and limit long-term health risks, the Liberate Medical device aims to provide therapy that reduces disuse atrophy of the abdominal wall muscles.

    By Maria Rachal • May 4, 2020
  • 7 states team up to buy $5B in ventilators, PPE to meet COVID-19 demand

    New York, New Jersey, Connecticut, Pennsylvania, Delaware, Rhode Island and Massachusetts are aiming to use their combined purchasing power to drive down prices amid rivalry with other states and even the federal government.

    By Rebecca Pifer • May 4, 2020
  • Ventilator sharing among states critical to save COVID-19 patient lives: Health Affairs paper

    Without a coordinated federal effort to promote the exchange of the breathing assist machines, thousands more Americans will die in the coming weeks as the virus continues its rampage across the U.S., a new paper warns.

    By May 4, 2020
  • Stryker sees 50% of revenue vulnerable to elective procedure pullback

    Despite making it out of Q1 with total sales up 2%, the medtech's U.S. orthopaedics and spine sales dropped roughly 65% in April after a near total halt in non-essential procedures due to the coronavirus pandemic.

    By Maria Rachal • May 1, 2020
  • Coronavirus surge in critical care sales helps Hillrom beat Q2 guidance

    The company on Friday said it is hiring 300 additional staff globally to enable a fivefold increase in production of non-invasive ventilators, while doubling output of other products in high demand for COVID-19 patients. 

    By May 1, 2020
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    COVID-19 spurs 'incredible demand' for ventilators, buoying ResMed's 16% revenue uptick

    CEO Mick Farrell told investors sales of breathing assist machines added $35 million in coronavirus-related revenue. However, sleep testing declined by double digits.

    By May 1, 2020
  • Medtronic continuous dialysis system designed for small children gets FDA nod

    The De Novo authorization, one of a only a handful doled out by the agency so far this year, gives Medtronic a chance to dominate a pediatric niche. Baxter tested a similar system but terminated the study in 2018.

    By May 1, 2020
  • Abiomed acquired Breethe's ECMO system with an integrated oxygen concentrator.
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    Retrieved from Abiomed/BusinessWire on April 30, 2020
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    Abiomed buys artificial lung device for use with Impella, potential COVID-19 patients

    The addition of a novel ECMO system comes as management attributed declines in recent heart pump sales to lingering negative sentiment following a pair of studies released last year and the pandemic's impact on procedures.

    By Maria Rachal • April 30, 2020
  • Hologic to launch 2nd coronavirus test amid broader sales slide

    The molecular diagnostics business posted its best growth rate in eight years, but the breast health and surgical segments slowed as a result of postponed elective surgeries.

    By April 30, 2020
  • Teleflex yanks guidance as coronavirus craters key product

    Sales of UroLift plummeted 64% in the last two weeks of March, wiping out an important growth driver.

    By April 30, 2020
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    Baxter cites 'extraordinary' Q1 demand from customers fighting coronavirus

    Revenues grew 6% to $2.8 billion thanks to growth across all six of the company's global business units and three geographic segments.

    By April 30, 2020
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    AdvaMed pushes US to lift tariffs on Chinese imports of COVID-19 devices

    The trade group wants indefinite exemptions for imaging components and devices used in ventilators, among other items. It also floated a compromise: re-imposing them one year after the pandemic passes.

    By April 30, 2020
  • Boston Scientific sees April sales cut in half amid coronavirus

    One potential area of optimism: two-thirds of the device giant's business comes from procedures in outpatient settings like ambulatory surgery centers and physicians offices, which the company expects will resume operations sooner.

    By Maria Rachal • April 29, 2020
  • Dexcom's hospital strategy accelerates, but next-gen iCGM path slows

    The continuous glucose monitor manufacturer recorded its highest number of new users ever during the first quarter as it topped Wall Street revenue estimates by around $50 million, weathering a dip in business in late March.

    By Maria Rachal • April 29, 2020
  • GE reducing healthcare headcount in $700M cost-cutting drive

    The cuts come as the conglomerate seeks to adapt its business to volatility and pressures created by the global coronavirus pandemic.

    By April 29, 2020