Policy & Regulation


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    Biden admin investing $1.5B to quell healthcare staffing shortages, promote workforce equity

    The funding is meant to address staffing shortages that have been exacerbated by the pandemic and impacted the entire healthcare industry, from hospitals to medical device companies.

    By Hailey Mensik • Nov. 24, 2021
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    FDA beats 2021 facility inspection target but big pandemic-driven backlog remains

    The update features evidence of progress at the device division, with fewer application decisions delayed solely because of pending facility inspections or assessments.

    By Nov. 23, 2021
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    Trendline

    COVID-19 diagnostics surge as industry prepares for spike in at-home testing

    With strong demand once again for rapid at-home coronavirus tests, medtech companies are looking beyond COVID-19 to sell over-the-counter and direct-to-consumer diagnostics for other diseases. 

    By MedTech Dive staff
  • CMS proposes smokers begin lung cancer screening at age 50 instead of 55

    The agency is revisiting its national coverage determination to catch the disease at an earlier stage. Needham analysts say a larger pool of patients will drive demand for test makers Veracyte, Oncocyte and NeoGenomics.

    By Nov. 22, 2021
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    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
  • FDA shakes up hepatitis C testing market by opening up 510(k) pathway

    Lowering the barrier to the market could increase competition in spaces targeted by companies such as Abbott Laboratories and Roche. 

    By Nov. 22, 2021
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    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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    FDA, aiming to curb another COVID-19 surge, clears Pfizer, Moderna boosters for all adults

    The decision comes as at least 10 states have already begun opening up booster dose eligibility, with cases remaining at high levels across the country. 

    By Ben Fidler • Nov. 19, 2021
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    Medtronic leadless pacemaker flagged by FDA for safety risks

    The agency said in a letter to healthcare providers that cardiac perforations associated with Medtronic's Micra device are more likely than traditional pacemakers to be associated with serious complications, such as death.

    By Nov. 18, 2021
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    30% of hospital healthcare workers remained unvaccinated as of September

    Healthcare workers in children's hospitals had the highest vaccination rates, along with those working in metropolitan counties, according to the analysis of Centers for Disease Control and Prevention data.

    By Hailey Mensik • Nov. 18, 2021
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    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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    FDA to regulate lab developed tests in policy reversal

    HHS is withdrawing a Trump-era policy that exempted LDTs from premarket review. The American Clinical Laboratory Association warned continually shifting policies "undermines patient access to lifesaving diagnostics."

    By Nov. 16, 2021
  • FDA questions safety of Philips replacement foam for recalled devices

    The agency has asked Philips Respironics to conduct more safety testing on the sound abatement foam at the center of the sleep apnea and ventilator device recall, but did not recommend that patients stop using the machines.

    By Nov. 15, 2021
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    FDA panel finds need for surveillance of devices from Endologix, Medtronic and others

    Experts convened earlier this month by FDA warned the risks of routine use of Endologix's current endovascular graft device outweigh the benefits.

    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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    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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    Siemens software vulnerabilities potentially put millions of medical devices at risk

    A U.S. cybersecurity agency issued an alert about the vulnerabilities which could allow hackers to disrupt the operation of anesthesia machines and bedside monitors from multiple manufacturers.

    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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    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
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    Robotics startup Vicarious files pre-submission with FDA, fresh from $220M SPAC raise

    The filing is part of a push to establish the robotic surgical system in a space fought over by Intuitive Surgical, Johnson & Johnson and Medtronic.

    By Nov. 9, 2021
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    iRhythm's COVID-19 pressures add to Medicare pricing saga

    New CEO Quentin Blackford told investors "significant" customer staffing issues are likely to drag on through Q4, limiting the company's capacity and forcing it to lower 2021 guidance.

    By Nov. 5, 2021
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    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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    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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    CMS finalizes plans for pay cuts for radiation oncology, other specialists

    Device makers could feel the pinch in cuts to services that use pricey equipment for vascular surgery, interventional radiology and diagnostic testing, which AdvaMed contends will decrease patient access to care.

    By Shannon Muchmore • Nov. 3, 2021
  • CMS reinstates Medicare's inpatient-only list in final rule, reversing Trump-era nix

    Medtronic, Johnson & Johnson, Stryker and Zimmer Biomet overwhelmingly supported restoring the IPO list in public comments to the July proposed rule. The backing comes as the industry also embraces outpatient care.

    By Nov. 3, 2021
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    Outset nabs first CMS home dialysis add-on payment, setting up fight with Fresenius

    The company, whose application was rejected last year, persuaded the Medicare agency its portable dialysis machine is a "substantial clinical improvement" over the incumbent home-use hemodialysis product.

    By Nov. 3, 2021