Digital Health


  • Roundup: COVID-19 surge, hospital labor shortages, supply chain issues hit medtechs in latest earnings

    After the industry began recovering in the first half of the year, top companies reported that the delta variant surge put a drag on businesses last quarter.

    Nov. 23, 2021
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    Sarah Silbiger via Getty Images

    Latest breakthrough device designations go to brain-computer interface, exo-suit

    Regulatory privileges were awarded to Blackrock Neurotech's brain-computer interface, designed to assist immobile patients with performing activities, and ReWalk Robotics' exo-suit, which is intended to help stroke patients walk. 

    By Nov. 22, 2021
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    Permission granted by iRhythm Technologies
    Q&A

    New iRhythm CEO talks Medicare pricing, larger medtech competitors, international markets

    "I think the near-term noise is something that we'll work through, but the underlying technology has never been questioned," Quentin Blackford told MedTech Dive.

    By Nov. 19, 2021
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    Megan Quinn/MedTech Dive

    MCIT breakthrough device payment pathway included in Cures 2.0 bill

    Lawmakers on Tuesday introduced a revised MCIT proposal in the next version of the 21st Century Cures Act, following last week's repeal of the final rule by CMS. Industry groups AdvaMed and MDMA both back the legislation.  

    By Nov. 17, 2021
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    Spencer Platt via Getty Images

    BD's $2B annual M&A war chest, connected care devices at heart of growth plan

    Evercore ISI analysts said the targets and messaging were consistent with expectations, while J.P. Morgan questioned why it is taking BD longer than its peers to return margins to pre-pandemic levels.

    By Nov. 15, 2021
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    Biden nominates Robert Califf to return as FDA head

    If confirmed, the cardiologist would return to lead an agency taxed by a heavy COVID-19 workload and a backlog of initiatives back-burnered amid the pandemic.

    By Ned Pagliarulo , Jonathan Gardner • Updated Nov. 12, 2021
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    Courtesy of Dexcom, Nick Jonas Super Bowl kit

    After another successful quarter, diabetes tech players look ahead to key product launches

    Dexcom's new G7 CGM system is expected to gain CE mark clearance in Q4, and Insulet's Omnipod 5 insulin pump is on track for FDA clearance and a limited launch by the end of the year.

    By Nov. 11, 2021
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    Medtech sounds alarm on semiconductor shortages, asks feds to prioritize chips for medical use

    AdvaMed and several device companies, including BD, Medtronic and Philips, have reiterated to the Biden administration how supply chain constraints are causing an "unsustainable" disruption to the industry.

    By Nov. 10, 2021
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    Alex Wong via Getty Images

    CMS repeals MCIT breakthrough device final rule, leaves open other coverage pathways

    The agency on Friday officially rescinded the Medicare Coverage for Innovative Technologies rule due to safety concerns following strong opposition from some healthcare groups, despite strong support for the rule in the medtech industry.

    By Updated Nov. 12, 2021
  • Philips grows cardiac monitoring business with Cardiologs pickup

    Nearly one year after announcing its $2.8 billion acquisition of BioTelemetry, the Dutch conglomerate is further expanding its reach in remote patient monitoring with the purchase of France-based Cardiologs.

    By Nov. 9, 2021
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    Sarah Silbiger via Getty Images

    FDA issues long-awaited draft software guidance in overhaul of 16-year-old policy

    The proposal applies to all types of premarket submissions and includes both software in and Software as a Medical Device.

    By Nov. 4, 2021
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    Adeline Kon/Healthcare Dive/MedTech Dive
    Deep Dive

    Why are women more likely to use telehealth?

    As Washington mulls over telehealth regulations post-COVID-19, it's important not to roll back access in a way that could disproportionately affect women, experts say.

    By Rebecca Pifer • Nov. 3, 2021
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    Sarah Silbiger via Getty Images

    Siemens' Varian leads latest FDA breakthrough device designations

    Varian secured the regulatory privileges for its noninvasive treatment of knee osteoarthritis based on technology acquired from Boston Scientific. Magnus Medical, Renovia and MY01 are included in the latest batch of designations.

    By Nov. 1, 2021
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    Sarah Silbiger via Getty Images

    FDA, global peers create guiding principles for AI/ML medical devices

    The U.S., U.K. and Canada are seeking international harmonization as part of a broader discussion on the development of safe, effective devices that use artificial intelligence and machine learning.

    By Oct. 29, 2021
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    What does J&J's Ottava delay mean for Intuitive and Medtronic? It's complicated.

    The setback doesn't remove hurdles the rivals face playing catch-up to market leader Intuitive's da Vinci, which has a two-decade head start. 

    By Oct. 28, 2021
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    Sarah Silbiger via Getty Images

    FDA's 2022 A-list guidance plan hits on software, post-pandemic future

    The agency's priorities include a much-anticipated final guidance on clinical decision support software — more than five years in the making — meant to clarify when CDS meets the definition of a medical device.

    By Oct. 27, 2021
  • Like 'Whac-A-Mole': GE Healthcare says supply chain woes to last into 2022

    "I'm not sure we're yet in a place where we would say that things are stable," GE CEO Larry Culp told investors Tuesday. The healthcare unit took the biggest hit among the conglomerate's business lines due to delays.

    By Oct. 26, 2021
  • Notified bodies join chorus of criticism of proposed European AI regs

    Team-NB has come out strongly against the regulation, arguing it will add to administrative burdens, reduce notified body capacity and create confusion.

    By Oct. 26, 2021
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    Cigna expands telehealth benefits for employer-covered lives, including new virtual-first plan

    The virtual-first plans will initially be available to large, self-insured employers, though the insurer is looking to expand to smaller and fully insured clients.

    By Rebecca Pifer • Oct. 26, 2021
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    Rebecca Pifer/MedTech Dive

    Amazon teases 5 more cities to get virtual Amazon Care offering this year

    Amazon Care is currently live in the Washington, D.C. and Baltimore area, and will be rolled out in Dallas, Chicago, Philadelphia, Boston and Los Angeles this year, the unit's director told the HLTH conference this week.

    By Rebecca Pifer • Oct. 22, 2021
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    Permission granted by Medtronic, Megan Rosengarten
    Q&A

    Medtronic surgical robotics head talks Hugo, taking on Intuitive, COVID-19 challenges

    Megan Rosengarten spoke to MedTech Dive about challenging Intuitive Surgical's 20-year lead in soft tissue robotics, growing global robotics usage and the stress of entering a new market amid COVID-19.

    By Oct. 20, 2021
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    Alex Wong via Getty Images

    In last ditch plea to save MCIT, medtech groups suggest fixes to CMS

    AdvaMed and MDMA responded to a call for feedback on the planned repeal of the Medicare Coverage of Innovative Technology pathway by proposing tweaks and new ideas to salvage it.

    By Oct. 20, 2021
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    Sarah Silbiger via Getty Images

    Medtechs need strategy to prevent bias in AI-machine learning-based devices: FDA

    The agency is mulling the types of information medtechs might include in labeling for such devices to support transparency. A Philips rep cautioned about the pitfalls of "information overload."

    By Oct. 15, 2021
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    Win McNamee via Getty Images

    Biden circling former FDA chief Califf to again lead agency: report

    The Washington Post reported the administration was "closing in" on the choice, citing unnamed sources. Still, the White House declined to comment and Califf could face opposition from Senate Democrats.

    By Oct. 15, 2021
  • Medtronic pledges R&D boost, brand refresh, amid rising Big Tech rivalry

    CEO Geoff Martha said the device giant is still "building out that direct-to-consumer muscle" and acknowledged "healthy competition" with the likes of Apple and Google.

    By Oct. 14, 2021