Clinical / R & D
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Clinical Trials
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![](/-/media/editorial/pink-sheet/2024/06/ps2406_diverse_hands_301651463_1200.jpg?rev=e94416a40ed04cb3825554eeca56a054&w=350&hash=75D1B0EF7B23746889B85F28E24F70AA)
Diversity Action Plans Should Be Brief And Waiver Requests Filed Early, US FDA 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In what could amount to a de facto enforcement mechanism, the new draft guidance also “strongly encourages” sponsors to share details about their diversity action plan and enrollment goals with the public.
![](/-/media/editorial/pink-sheet/2024/06/ps2406_overflowingcoffeecup_1735709915_1200.jpg?rev=2c54db96311a4c578c3520e94a6d0ba0&w=350&hash=696B7C445050175118FAB20500637C84)
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New draft guidance on clinical trial diversity action plans pushes for disproportionately high enrollment of traditionally underrepresented groups, while also asking companies to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.
![](/-/media/editorial/medtech-insight/2024/06/mti2406_medtechbrain_bio_banner_1200.png?rev=fba3f341049f4853a5cbc7743c6bba55&w=350&hash=5F3B4F4B9E31872CDE789F4C14A27049)
ADDF Leaders Discuss Future Strategies In Alzheimer’s Research And Crucial Role Of Diagnostic Markers
Medtech Insight talked to two leaders at the Alzheimer’s Drug Discovery Foundation about current therapies and the role of biomarkers and digital tools to build on recent advancements in the space and accelerate progress to identify the disease early and slow cognitive decline.
![](/-/media/editorial/medtech-insight/2024/06/mti-trialdiversity-1200.jpg?rev=41f153ea41fa4da79adbf46d1cdb6b0f&w=350&hash=CD1A6FD2EE0DBBFE176B0D4A54DF335E)
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.
New Technology
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![](/-/media/editorial/hbw-insight/hbw-stock-2021/expand_252241552_1200.jpg?rev=3ec69b57f6aa4079a5662be33610c362&w=350&hash=782C4101544953220A32DDD895996CB6)
FDA To Add Ophthalmic And Orthopedic Devices To TAP Pilot
The program, which brings together innovators and device industry stakeholders, helps ease the path to market for novel devices.
![](/-/media/editorial/medtech-insight/00_regular-column-images/topstorieseu_1200x675.jpg?rev=43eaab3b500d4792b1bcd1eb49f7fccb&w=350&hash=525A50C0301919FB94AB5BC0080EA1C7)
EU Regulatory Roundup, May And June 2024: Sweeping New Proposals Take Medtech By Surprise
During this period of intense regulatory pressure for the medtech industry, work has been ongoing in the background to try and find a better way forward for the medtech industry, for innovation and for patients.
![](/-/media/editorial/medtech-insight/00_regular-column-images/mti2301_newswerewatching_1200.png?rev=688714c023c14838b737c7a06cd71521&w=350&hash=96B7B2D80A4AD95988467585BE50FE74)
News We're Watching: Change Healthcare Details Breach Scope, CHAI Releases AI Assurance Draft, FDA Partners With Gates Foundation
This week, Change Healthcare admittedi ts February breach revealed sensitive information like medical diagnoses and Social Security Numbers; the Coalition for Health Artificial Intelligence released its Assurance Standards Guide and Reporting Checklist for developers; and the FDA announced public meetings in July on IVD classification, the Home as a Health Care Hub initiative, and device sterilization.
![](/-/media/editorial/medtech-insight/2024/06/mti2406_hlthamsterdam_1200.png?rev=6b7af60aca014596bc877f708ddb1a5d&w=350&hash=D66DAEAA6912C1D3576B84CF524A25A9)
Healthtech Leaders Discuss Impact (And Risks) Of Generative AI and AI In Health Care
AI and generative AI ruled much of the discussion at HLTH Europe 2024. A panel of health care leaders from Microsoft, Philips, insitro and Johnson & Johnson discussed how these new technologies are already transforming health care and pointed to risks and challenges.
Approvals
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![](/-/media/editorial/medtech-insight/2024/06/mti2406_orthopedic_1926790544_1200.jpg?rev=7ef5750f79c54a8bb00b440110c5e700&w=350&hash=F5BC6DA93098436C2E2FA033E1C79A54)
Pediatric Orthopedic Device Drought Continues, Study Finds
A recent review of orthopedic device approvals between 2018 and 2022 found that less than 10% of 510(k) devices – and less than 5% of PMA and de novo products – have been authorized for use in children, highlighting the ongoing lack of pediatric devices.
![](/-/media/editorial/medtech-insight/00_regular-column-images/mti2310_regulatory_newswerewatching_1200.png?rev=06b8861f919a46c7b847b473a0f696e5&w=350&hash=17E8438B028A603A910C876BD3A46B1D)
News We’re Watching: DMCA Judicial Review Upheld; Abbott’s Rio CGM Available OTC; J&J’s Velys Wins FDA UKA Expansion
This week, AdvaMed and MITA win appeal to prevent repair companies from hacking medical devices, the FDA cleared Abbott’s Libre Rio CGM for OTC sales, J&J MedTech wins expanded clearance for Velys knee medical robot, the FDA updates its AI program, Canary Speech secures $13m in series A funding and Xeltis won FDA approval for an IDE submission to begin enrolling patients for a pivotal study for aXess.
![](/-/media/editorial/medtech-insight/00_regular-column-images/mti2301_newswerewatching_1200.png?rev=688714c023c14838b737c7a06cd71521&w=350&hash=96B7B2D80A4AD95988467585BE50FE74)
News We’re Watching: Medtronic Recall, More Chinese Syringe Woes, Surgical Robot Clearance
This week, Medline announced recalls of tracheal tubes; Eko Health raised $41m in Series D funding; and the US FDA announced participation in collaborative communities focused on brain-computer interface devices and more.
![](/-/media/editorial/products/l/lingo_1200.jpg?rev=c828c7c7a54246d682b3b6e05e500149&w=350&hash=191EE6888CDB747BE5222014F014BB95)
Abbott’s Lingo Becomes Second FDA-Cleared OTC Blood Glucose Monitor
The FDA has given the green light to over-the-counter sales of Abbott’s Lingo blood glucose monitoring device, which is intended for use by healthy people who want to track the crucial biomarker.
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