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Analyst Articles

  • Medtech Insight: 世界の医療機器・医療技術の最新情報

    FDA Will Keep Listening To Patient-Engagement Experts

    FDA_Will_Keep_Listening

    The US agency says in a 6 January Federal Register notice that it’s keeping its Patient Engagement Advisory Committee in place through October 2021 so it can gather more patient feedback that will come in handy when regulatory decisions need to be made. The committee, formed after the agency made a cultural shift to consider patient input on the types of products it allows on the market, was supposed to expire October 2019.

  • Medtech Insight: 世界の医療機器・医療技術の最新情報

    FDA Launches Pilot Program To Streamline EtO Facility, Process Changes

    Article

    As concerns continue to mount over a potential shortage of medical devices due to the closure of ethylene oxide (EtO) facilities, the US agency is looking for nine sterilizers in a pilot project that could allow them to get facility and process changes approved faster.

  • Medtech Insight: 世界の医療機器・医療技術の最新情報

    Listen: Medtronic Exec Highlights Ethylene Oxide Standards At First Day Of FDA EtO Meeting

    Medtronic’s director of quality sterilization and microbiology, Phil Cogdill, sat down with Medtech Insight to talk about setting new ethylene oxide (EtO) standards and what his takeaways were from the first day of a US FDA meeting to understand how to mitigate potential product shortages from closures of EtO sterilization facilities. Check out our podcast here.

    Topic fda

  • Medtech Insight: 世界の医療機器・医療技術の最新情報

    One Small Step For US FDA, But Maybe A Giant Leap For SaMDs

    One Small Step For US FDA, But Maybe A Giant Leap For SaMDs

    In a midyear update from the FDA, regulators say a retrospective review of companies in its pre-cert pilot program has concluded that evaluating a company for excellence markers could be sufficient to let Software as a Medical Device (SaMD) onto the market. However, at least one critic says the update doesn’t answer some of the most critical questions about whether the program meets the agency's own requirements and if it creates unfair advantages for certain companies.

    Topic FDA Policy and regulation

  • Medtech Insight: 世界の医療機器・医療技術の最新情報

    If You Build It, They Will Come: FDAer Says Pre-Cert Program Getting Global Attention, AI Paper Just the Start

    If You Build It, They Will Come: FDAer Says Pre-Cert Program Getting Global Attention, AI Paper Just the Start

    International regulators are interested in seeing how they too can apply the US FDA’s precertification program, which is currently in the pilot stage. In an exclusive interview with Medtech Insight, the agency’s top digital health officer, Bakul Patel, talks about global curiosity about the program that could allow companies to get certain medical software on the market based on trust. Patel also expects an upcoming artificial intelligence draft guidance from the FDA will form from a recent discussion paper – but he says industry needs to do more.

    Topic medtech

  • Medtech Insight: 世界の医療機器・医療技術の最新情報

    US FDA Asks Prostate Ablation Device-Sponsors For More Clinical Safety Data To Support Clearances

    US FDA Asks Prostate Ablation Device-Sponsors For More Clinical Safety Data To Support Clearances

    Almost four years after the agency first authorized a prostate ablation device, regulators have proposed a number of requirements for clinical studies that sponsors would have to meet to comply with special controls needed for the devices to be cleared for marketing.

    Topic fda medtech policy-and-regulation

  • Pink Sheet: 世界の薬事規制と承認審査に関するニュース

    AdvaMed Floats Legislation To Allow User-Fee Submissions During Shutdowns

    AdvaMed Floats Legislation To Allow User-Fee Submissions During Shutdowns

    As the partial US government shutdown enters its second month, the backlog of device pre-market applications is building. AdvaMed is proposing language that would allow FDA to accept and review new user-fee-funded submissions during government shutdowns.

    Topic US-Shutdown fda

  • Medtech Insight: 世界の医療機器・医療技術の最新情報

    After AdvaMed, Yared Takes Helm Of MDIC Board

    After AdvaMed, Yared Takes Helm Of MDIC Board

    CVRx CEO Nadim Yared has moved up on the board of directors at the Medical Device Innovation Consortium as its new chair. The public-private partnership group that formed in 2012 has been effective in working with the US Food and Drug Administration to develop new regulations.

    Topic policy-and-regulation business-strategies

  • Medtech Insight: 世界の医療機器・医療技術の最新情報

    Testing For Toxicity In Fertility Treatment Technologies

    Testing For Toxicity In Fertility Treatment Technologies

    US regulators are proposing makers of fertility assistant devices first test their products on mice embryos in the lab to better understand any potential toxicity risk to human embryos and the viability of the fetus.

    Topic FDA Policy and regulation

  • Medtech Insight: 世界の医療機器・医療技術の最新情報

    Top Medtech Lobbyist Doubts Legislative Repercussions Of New Netflix Documentary

    Top Medtech Lobbyist Doubts Legislative Repercussions Of New Netflix Documentary

    AdvaMed's top lobbyist says a new documentary critical of the medical device industry and US FDA's device review pathways is unlikely to result in Congressional action. However, the group is talking to members on Capitol Hill to make sure they fully understand the context within which devices are reviewed and marketed.

    Topic fda medtech

  • Medtech Insight: 世界の医療機器・医療技術の最新情報

    2019 Will Be Testing Period For US FDAs Novel Pre-Cert Paradigm For Digital Health

    2019 Will Be Testing Period For US FDAs Novel Pre-Cert Paradigm For Digital Health

    In 2019, FDA will be taking steps to perform real-world testing of the effectiveness of its pre-cert program for health software and whether the program can be carried out within the agency's current regulatory authorities. The efforts come after more than a year of development and some pushback about statutory overreach and patient safety.

    Topic fda

  • Medtech Insight: 世界の医療機器・医療技術の最新情報

    New Device Tax Repeal Bills Are Coming, With Candidate Klobuchar's Help

    New Device Tax Repeal Bills Are Coming, With Candidate Klobuchar's Help

    Despite a recent report that Sen. Amy Klobuchar, D-Minn., is backing away from leading efforts to repeal the medical device tax due to her presidential ambitions, sources say she is working with Sen. Pat Toomey, R-Pa., to cosponsor a repeal bill this year. Similarly, on the US House-side, Rep. Ron Kind, D-Wisc., is calling on his colleagues to support a full repeal bill as well.

    Topic Medtech

  • Medtech Insight: 世界の医療機器・医療技術の最新情報

    Pathogen-Reduction Tech Gets Some Focus At FDA Panel Meeting, But Not Enough, Cerus Says

    Pathogen-Reduction Tech Gets Some Focus At FDA Panel Meeting, But Not Enough, Cerus Says

    While a panel of US FDA experts agreed pathogen reduction technology is a promising strategy for reducing blood platelet contaminations, they raised concerns about the cost of implementing the technology. The maker of the technology, Cerus, says the panel was under-briefed and distracted.

    Topic fda policy-and-regulation

  • Medtech Insight: 世界の医療機器・医療技術の最新情報

    Mercy, J&J Partner To Evaluate Medical Devices

    Mercy, J&J Partner To Evaluate Medical Devices

    As US FDA has been on a quest to encourage gathering more real-world data, companies like Medtronic and Johnson & Johnson seem to be hopping on the bandwagon with partnerships to gather and analyze how their products really perform.

    Topic medtech

  • Medtech Insight: 世界の医療機器・医療技術の最新情報

    US Homeland Security Sees Rapid Growth In Device Cybersecurity Vulnerability Reports

    US Homeland Security Sees Rapid Growth In Device Cybersecurity Vulnerability Reports

    A center inside the US Department of Homeland Security has seen a massive spike in the number of potential medical device cybersecurity vulnerabilities that it has responded to in the past year. The government says it reflects better collaboration and disclosure policies in industry.

    Topic Digital Health