Medical Devices: Page 113


  • BD Veritor system for rapid detection of SARS-CoV-2
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    Courtesy of BD/PRNewswire
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    BD sales slide below expectations, as COVID-19 antigen test gains momentum

    In the month since the launch of its antigen test, CEO Tom Polen said BD shipped more Veritor readers than in a typical year. Still, the medtech's stock fell 9% Thursday amid pressure on other business lines.

    By Aug. 6, 2020
  • Nevro blasts past analyst consensus on rebound in pain procedures

    The spinal cord stimulation device maker contends it picked up market share from rivals such as Abbott, Boston Scientific and Medtronic amid the pandemic.

    By Aug. 6, 2020
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    Sitthiphong via Getty Images
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    Trendline

    Medical device industry continues to turn to AI

    While the industry continues to embrace artificial intelligence, there are still questions about how the new technologies need to be regulated and if they are effective.

    By MedTech Dive staff
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    Fotolia
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    ResMed beats Street with ventilators driving revenue up 9%, but tailwinds ebbing

    "While we are still working on current and future contracts with hospitals, as well as city and national health authorities for these ventilators, the volumes will be significantly lower in the September quarter," said CEO Mick Farrell.

    By Aug. 5, 2020
  • NuVasive's spine robot sees delay, again

    Amid COVID-19 constraints, the Pulse application may not be used in humans until 2022 in a spinal robotics market some analysts call significantly untapped.

    By Maria Rachal • Aug. 5, 2020
  • Zimmer sees COVID-19 backlog worth up to $800M, aims to double Rosa robot volume by year's end

    Like rival Stryker, new placements of the company's robot-assisted knee replacement systems had traction during a second quarter when deferral of elective procedures took away over a third of its typical total revenue.

    By Maria Rachal • Aug. 4, 2020
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    Medtronic
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    Medtronic, in catch-up to Axonics, wins nod for rechargeable bladder and bowel control device

    After leading the sacral neuromodulation market for two decades, Medtronic is defending its turf with FDA approval of a product it contends is 80% smaller than its current device and 50% smaller than Axonics' rechargeable system.

    By Aug. 4, 2020
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    Brian Tucker / Healthcare Dive
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    CMS proposes eliminating inpatient-only list, in potential boon for ASCs

    The agency would begin by removing about 300 musculoskeletal-related services, which could further accelerate ambulatory surgery centers' important role as medtech customers.

    By Shannon Muchmore • Aug. 4, 2020
  • Device maker Q2 reports show optimism on COVID-19 recovery, but flare-ups keep guidance at bay

    Since March and April lows, business volume has improved sequentially. Still, many medtechs are tightlipped on what that may mean for financial performance for the rest of the year.

    By Maria Rachal • Aug. 3, 2020
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    U.S. House of Representatives
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    House panel asks IG to investigate Trump admin bungling of Philips ventilator deal

    The Subcommittee on Economic and Consumer Policy on Thursday sent a letter to the acting inspector general requesting a probe into findings that HHS overpaid by $500 million in a contract negotiated with the Dutch medtech. 

    By Updated Aug. 7, 2020
  • Varian sold to Siemens Healthineers in $16.4B all-cash deal

    Breaking with a trend of smaller medtech deal values in 2020, the pact will see radiation oncology equipment and software maker Varian Medical Systems operate as an independent company under Siemens Healthineers.

    By Maria Rachal • Updated Aug. 3, 2020
  • Stryker sales slump 24% on elective surgery hits, but Mako robot demand a 'pleasant surprise'

    Looking to the third quarter, "we expect the recovery to continue, but do not expect it to be linear, while local governments deal with varying degrees of resurgences," CEO Kevin Lobo said on an earnings call Thursday. 

    By Maria Rachal • July 31, 2020
  • J&J gets FDA breakthrough status for robot-assisted ablation device

    The designation gives the product, which combines technologies Johnson & Johnson acquired via takeovers of NeuWave Medical and Auris Health, more regulatory support and potentially speedier review.

    By July 31, 2020
  • Teleflex reports rapid rebound in UroLift sales, driving Q2 beat

    The medical device maker also disclosed an unspecified number of job cuts and a DOJ investigation during its earnings call Thursday.

    By July 30, 2020
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    Getty Images
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    Baxter takes $180M revenue hit in thick of COVID-19

    While acute therapies saw over 40% growth during the quarter, sales in Baxter's advanced surgery, medication delivery and pharma businesses were hurt by lower rates of hospital admissions and elective surgeries.

    By July 30, 2020
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    Getty Images
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    Falling FDA personnel costs soften 2021 medical device user fee hike

    The agency's required user fees for medical device submissions will rise 7.2% beginning in October.

    By July 30, 2020
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    Dollar Photo Club
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    Dexcom nixes plan to begin G7 launch this year

    After growing revenues 35% in Q2, the diabetes tech company is focused on building out manufacturing for its continuous glucose monitoring systems and re-emphasizing its direct-to-consumer advertising.

    By Maria Rachal • July 29, 2020
  • Boston Scientific sees sharp US recovery in Q2, CEO says 'procedures can't be deferred forever'

    Organic revenue was down 29% during the quarter but beat analyst estimates, thanks in part to new patients in the pipeline and procedures performed in outpatient settings.

    By Maria Rachal • July 29, 2020
  • FDA finalizes guidance on multiple-function devices after industry feedback

    The agency clarified its policies and regulatory practices governing devices that have at least one distinct function and one other purpose that is not subject to premarket review.

    By July 29, 2020
  • Smith & Nephew falls short of expectations, citing COVID-19 headwinds

    The medtech's sales slumped in the second quarter, causing first-half trading profit to miss analyst consensus by $53 million. Though CEO Roland Diggelmann called July a "good" month, he opted against sharing guidance.

    By July 29, 2020
  • Robot redux: Pandemic scrambles competitive timelines for Intuitive, J&J, Medtronic

    Surgeons expect a gradual recovery of robot-assisted procedure volumes in the back half of the year, but the outlook for new robot system placements in hospitals is less optimistic due to freezes in capital equipment budgets.

    By July 28, 2020
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    Photo by Getty; photo illustration by Michelle Rock / Medtech Dive

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    Medtech and COVID-19: 6 months into the public health emergency

    MedTech Dive examines where the industry stands with testing and the future of those emergency use-authorized diagnostics, as well as how it's adapting to a rebound in elective surgeries and various supply chain challenges.

    July 27, 2020
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    Photo by Getty; photo illustration by Michelle Rock / Medtech Dive

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    Deep Dive

    Medtechs reboot with patients, providers after elective surgeries bottom out

    Recovery of procedures critical to device companies came quicker than many in the industry expected. Now, device makers are adapting as business volumes normalize and COVID-19 continues to spread.

    By Maria Rachal • July 27, 2020
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    Photo by Getty; photo illustration by Michelle Rock / Medtech Dive

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    How COVID-19 is challenging and changing medtech supply chain management

    Four experts share insights on the supply and demand hangups medtechs have been working through during the pandemic, and a few early takeaways the industry can carry forward.

    By Maria Rachal • July 27, 2020
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    "Money" by Ervins Strauhmanis is licensed under CC BY 2.0
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    COVID-19 diagnostics emerging as prime investment target, SVB analysis shows

    Companies with tech involved in the pandemic response raised $1.3 billion over the first half of the year, with developers of tests and R&D tools enjoying a 62% increase in investment.

    By July 24, 2020
  • Edwards aims for 5% TAVR sales growth in 2020 after seeing demand bounce back

    Quarterly sales came in $25 million above the top end of the device maker's guidance, with 90% of its active sites having done TAVR procedures in May and June. Yet, there are concerns regarding a slowdown in new patient screenings.

    By July 24, 2020