Stakeholders Weigh In On UK’s Clinical Trials Diversity Draft

 
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As the consultation period draws to a close for the UK’s new inclusion and diversity guidance, researchers and sponsors are being invited to participate in a pilot next year to submit a diversity plan as part of their clinical trial application.

Cover Supplemental Breast Screenings, AdvaMed Urges Medicare

 

AdvaMed is calling on Medicare to provide coverage for supplemental screenings for women with dense breasts, an anatomical characteristic that puts them at a higher risk for cancer. The trade group says the lack of coverage for additional imaging results in many women not receiving potentially lifesaving follow-up.

FDA Advisory Committee Focuses On Improving Informed Consent For Patients Volunteering For Device Trials

 

The US FDA’s Patient Engagement Advisory Committee met Wednesday to discuss ways the agency can empower patients thinking about whether to participate in clinical trials of regulated medical products. Central to the committee’s discussion was not only the type of information patients need to evaluate when considering joining a study, but how that information should be presented to them.

Uncertainty Abounds With SEC Climate Reporting Rule Tied Up In Courts

 
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Despite questions surrounding the SEC rule, including disputes being litigated in the US Eighth Circuit, companies must prepare to meet the new climate disclosure requirements in addition to related mandates in California and abroad. Experts emphasize opportunities beyond compliance.


Medtech Warming Up To Benefits Of Australia’s Teletrials Initiative

 
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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.

FDA Looks To Achieve Greater Health Equity For Medical Device Access

 

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.

Medtechs Are Fully Engaged In Climate Change: ‘They Have No Choice’

 
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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.

FDA's LDT Overhaul Should Go Back To Congress, Appropriations Report Says

 

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. 


EU Guidelines On Justifying Phthalates In Medical Devices Applicable To Growing List Of Regulated Substances

 
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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.

EU’s Historic PFAS Restriction Looms Over Medical Devices Sector

 
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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.

Diversity Action Plans Should Be Brief And Waiver Requests Filed Early, US FDA Says

 
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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.

Diversity Enrichment: US FDA Guidance Suggests Sponsors May Need To Overenroll Key Groups

 

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. 


Physician And myTomorrows CEO Discusses FDA’s New Program To Advance Clinical Trial Diversity

 

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.

European IVD Industry On Rocky Road; Veer Toward 'Pockets of Growth'

 

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.

Hospital At Home: Great On Paper, Not In Practice

 
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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.

Digital Health Review Founder Blair Hirst Focuses On Health Equity

 
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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.


ICER Debuts Clinical Trial Diversity Assessment Framework

 
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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.

Alarming Rise Of Diabetes in Several US States, Study Shows

 

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.

Clinical Trial Diversity Requires Sponsors Work With An Assortment Of Patient Advocates, Community Organizations

 
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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’s CTO Beth McCombs Discusses Key Initiatives – AI/Gen AI; DE&I Strategy; Succession Planning

 
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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.