FDA: Page 37


  • Hospital leaders, Congress mull fixes to current staffing woes

    The omicron variant is posing new challenges as staff call in sick or quit their jobs entirely for higher-paying traveling nurse positions. That's leaving hospitals in a bind as they treat higher acuity COVID-19 patients.

    By Hailey Mensik • Feb. 11, 2022
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    Courtesy of Dexcom, Nick Jonas Super Bowl kit
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    Dexcom's G7 gains CE mark after 2021 delay

    The company’s newest continuous glucose monitoring system was expected to launch in Europe in 2021, but regulatory delays pushed the release back.

    By Updated March 14, 2022
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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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    FDA plan to harmonize device quality system rules clears OMB review

    The White House's Office of Management and Budget review positions FDA to publish a long-awaited proposed rule that is intended to bring the agency's quality system rules in line with international standards.

    By Feb. 10, 2022
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    BioCardia, Cook Medical land FDA breakthrough nods in latest designations

    Cardiovascular devices feature prominently in the tech granted regulatory privileges, including a drug-eluting stent for patients with chronic limb-threatening ischemia and a non-invasive cardiac monitoring device. 

    By Feb. 9, 2022
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    Roche partner recalls illegally imported rapid COVID-19 tests from US

    FDA said there are "confirmed reports" of unlawful importation of the Standard Q COVID-19 Ag Home Test and South Korea's SD Biosensor is looking into which distributors or people were involved.

    By Feb. 7, 2022
  • Abbott BinaxNOW home COVID-19 test
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    Abbott

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    Procedure volatility, testing uncertainty & FDA delays: Medtech trends in 2022

    As companies manage through the omicron surge, and with the threat of potential future variants, the medical device industry is facing another challenging year.

    Feb. 4, 2022
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    CDRH targets hiring, novel approvals among 2022-2025 strategic priorities

    FDA's Center for Devices and Radiological Health, whose staff continues to struggle with an unprecedented workload since the pandemic's start, is aiming to achieve at least 90% of its annual hiring targets for certain years.

    By Feb. 4, 2022
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    Breakthrough device program 'far exceeding' FDA expectations after record year

    The total number of products granted the agency's regulatory privileges in 2021 increased by more than 50%, while the number of novel devices that came to market fell compared to 2020.

    By Feb. 1, 2022
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    Deep Dive

    3 key FDA topics for medtechs in 2022

    While the agency is looking to get back to normal operations this year, COVID-19 is poised to remain a top priority and, once again, thin resources for more traditional work, such as product reviews.

    By , Feb. 1, 2022
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    FDA must improve medical device interoperability through data standards: JAMA

    The authors list a range of potential positive outcomes of improved device interoperability, using the experience of the consumer technology and telecommunications industries to make their case.

    By Jan. 31, 2022
  • Bose received FDA clearance for its newest over-the-counter hearing aids in May, 2021.
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    Courtesy of Bose
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    Senators urge FDA to finalize over-the-counter hearing aid rule

    Sen. Elizabeth Warren, D-Mass., and Sen. Chuck Grassley, R-Iowa, are asking the FDA to finalize a rule that would create a class of over-the-counter hearing aids, without implementing changes suggested by manufacturers. 

    By Updated Feb. 9, 2022
  • Healthcare workers at Catholic Health's Mercy Hospital in Buffalo, New York, wage a strike.
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    Permission granted by Communication Workers of America
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    Deep Dive

    3 key labor trends for hospitals in 2022

    Hospitals are still grappling with rising turnover, widespread burnout and numerous staff calling in sick nearly two years after the pandemic began. It's unclear when it might get better — or how much worse it could get.

    By Hailey Mensik • Jan. 27, 2022
  • Philips' problems grow as FDA labels expanded ventilator recall Class I event

    The agency's new notice expands the company's June recall, which has grown to over 5 million affected devices. Jefferies analysts said it is "immaterial to financials but will negatively impact sentiment."  

    By Jan. 27, 2022
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    Deep Dive

    4 key trends for procedure-reliant medtechs in 2022

    Medical device companies likely will face the same challenges this year that they have been dealing with since the pandemic's start, such as procedure volatility and hospital staffing shortages.

    By Jan. 27, 2022
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    FDA finalizes two guidances on including patient perspectives in medtech clinical trials

    The documents, which elaborate on how to engage patients to improve trial design and use patient-reported outcomes, are based on feedback from groups like AdvaMed which raised concerns about "significant" legal issues.

    By Jan. 26, 2022
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    J&J's device recovery slowed by omicron surge, with impact expected over next several months

    CFO Joseph Wolk said that the medtech giant expects pressure from COVID-19 and hospital staffing shortages to continue through the first half of 2022, with businesses recovering month by month.

    By Jan. 25, 2022
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    Medtronic
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    Medtronic gets earlier-than-expected FDA approval for pain device, raising concerns among Nevro investors

    The premarket approval, which Medtronic wasn't expected to seek until 2023, positions it to compete with Nevro for a market it values at $1.8 billion.

    By Jan. 25, 2022
  • Medtronic's HawkOne recall labeled Class I, adding to medtech's product safety problems

    FDA posted 10 Class I recall notices for Medtronic in 2021 and three so far this year. CEO Geoff Martha addressed the recalls and an FDA warning letter at the J.P. Morgan conference, claiming the company will increase accountability.

    By Jan. 21, 2022
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    Boston Scientific, Sterigenics start tracking ethylene oxide emissions under new EPA rules

    Beginning this month, 29 medical device sterilization facilities must comply with EPA's Toxics Release Inventory reporting requirements for EtO, which has been determined to cause cancer in humans and damage DNA.

    By Jan. 21, 2022
  • A staff member from McSwain Union Elementary School District in Merced, California participates in the district's voluntary COVID-19 testing pilot.
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    Diagnostics makers ride omicron surge in COVID-19 test demand. But for how long in 2022?

    The highly transmissible variant caused the Biden administration to announce plans to buy 1 billion rapid tests to provide free to Americans. However, when testing will ramp back down remains an open question.  

    By Jan. 20, 2022
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    FDA misses MDUFA V deadline after months of contentious talks

    The agency has failed to send the final MDUFA V user fee agreement to Congress by the Jan. 15 deadline, suggesting there may be unresolved disagreements with industry over elements of the program.

    By Jan. 19, 2022
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    CDRH pledges greater focus on women's health data

    The center's strategic plan creates a framework for addressing FDA's priorities in the area of women's health, including representation in biomedical research.

    By Jan. 19, 2022
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    Digital therapeutics face barriers to growth as Pear takes early steps toward sales targets

    Among the challenges facing DTx are lack of support for rapid updates, limitations of current reimbursement policies, cybersecurity risks as well as a "pressing need" for new regulatory frameworks, according to researchers.

    By Jan. 19, 2022
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    Permission granted by Dexcom
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    Q&A

    Dexcom CEO on G7's global launch, COVID-19 slowing new patient adds, international growth

    Kevin Sayer spoke to MedTech Dive about the upcoming launch of the G7 CGM system, further expanding Dexcom ONE and feeling pandemic pressure in the fourth quarter.

    By Jan. 18, 2022
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    Cybersecurity leads ECRI's list of top medtech hazards for 2022

    Cyber incidents can compromise patient care and attacks against hospitals have become more prevalent in recent years. However, ECRI said the worst consequences are preventable.

    By Jan. 18, 2022