The Australian teletrials program has surpassed expectations at its mid-way point and is being used by drug and device sponsors looking to enhance trial participant recruitment and retention by enabling access to rural, regional and remote areas.
The US FDA has published a discussion paper as part of an effort to ensure all patients have timely access to safe and effective medical devices. The agency says the paper fits into a larger strategy of promoting health equity and is seeking public comment on the initiative.
The E in ESG: SUDs, reuse, disposables, refurbishing, reprocessed devices? Multiple panelists at the 2024 MedTech Forum addressed the role medtech manufacturers should have in the climate change challenge.
A fiscal 2025 report from the US House Appropriations Committee instructs the FDA to halt implementation of its overhaul of LDT regulation. Members also showed concern about overseas device manufacturing and the availability of over-the-counter diagnostics.
The European Commission’s Scientific Committee on Health, Environmental and Emerging Risks makes minor changes to its phthalates benefit-risk guidelines based on stakeholder feedback. The guidelines could be increasingly relevant given their applicability to other carcinogenic, mutagenic or reprotoxic (CMR) and endocrine-disrupting (ED) substances, lists that are bound to go on growing as the EU implements its Chemicals Strategy for Sustainability under the Green Deal.
The European Chemicals Agency’s committees for Risk Assessment (RAC) and Socio-Economic Analysis (SEAC) are evaluating sector by sector the proposed REACH restriction on PFAS and more than 5,600 public comments, reaching provisional conclusions on cosmetics at their June meetings. A date has not been set to consider PFAS uses in medical devices, which are numerous, essential, and in many cases devoid of alternatives, industry says.
In what could amount to a de facto enforcement mechanism, the new draft guidance also “strongly encourages” sponsors to share details about their diversity action plan and enrollment goals with the public.
New draft guidance on clinical trial diversity action plans pushes for disproportionately high enrollment of traditionally underrepresented groups, while also asking companies to tailor global programs to US populations and consider diversity aspects that Congress did not outline.
The US FDA recently announced a new initiative aimed at improving access to cancer trials among traditionally underserved populations. myTomorrows CEO Michel van Harten talked to Medtech Insight about how the agency’s plan might reshape the landscape of clinical trials going forward.
Despite challenges and projected European decline, the in vitro diagnostics market has enticing "pockets for growth" post-pandemic, industry leaders revealed at the MedTech Forum conference. Key drivers include healthcare decentralization and consumer pull for control over health. Opportunities exist in neurology, oncology, and direct-to-consumer testing.
To avoid a wider health equity gap for home-use devices, companies should make social determinants of health a key consideration in device development, former nurse Amy Hester says.
As a biomedical engineer, Blair Hirst saw how health technology could help patients – and how some communities were slowest to benefit. As founder of the Digital Health Review, she now works to improve equity in health care spaces.
The new tool provides a way of quantifying the degree of diversity by race/ethnicity, sex and age in clinical trials, but the results will not factor into the US health technology assessment body’s cost effectiveness determinations for new drugs.
A study of diabetes rates across the US over four years reveals significant increases in the disease in many states. Tobias Oerum, diabetes advocate and cofounder of the company that conducted the study, discussed the data and some of the factors contributing to this troubling trend with Medtech Insight.
US FDA oncology officials are concerned that the entities sponsors are consulting in developing and implementing clinical trial diversity plans are not sufficiently diverse themselves and do not represent patients in underserved communities.
BD CTO Beth McCombs discusses her role in driving innovation, including the integration of AI and generative AI to create efficiencies, and passion for creating a culture of inclusion, diversity and equity.
President Joe Biden signed an executive order the White House said represents the most comprehensive executive action to date on improving women’s health. The move follows the president’s call during his State of the Union for Congress to invest $12bn in women’s health research.
The rule, which requires most device sterilization plants to track and report their EtO emissions, will go into effect in two years for the largest plants and three years for the smallest.
Marissa Fayer is dedicated to advancing women’s health. The founder and CEO of HERhealthEQ, a global nonprofit focused on women’s health equity in emerging and developing countries, Fayer is also the CEO of DeepLook Medical. As part of our focus on women’s health in honor of Women’s History Month, Fayer spoke to Medtech Insight about the importance of having more women in all sectors of medtech, both for the benefit of industry as well as women patients.
Healthtech innovators are being asked by users and clinicians how technology solutions can increase health system efficiency and respond to concerns over staff shortages. Royal Philips’ Bert van Meurs fielded these questions at ECR 2024.