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Clinical Trials

Set Alert for Clinical Trials

FDA Drops Final Guidance On Devices Designed To Treat Opioid Abuse

The FDA has published final guidance to assist developers of medical devices designed to treat opioid use disorder, along with considerations for sponsors of clinical studies to evaluate those devices.

FDA Guidance Documents

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. 

Legislation Regulation

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In what could amount to a de facto enforcement mechanism, the new draft guidance also “strongly encourages” sponsors to share details about their diversity action plan and enrollment goals with the public.

Diversity & Inclusion Clinical Trials

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New draft guidance on clinical trial diversity action plans pushes for disproportionately high enrollment of traditionally underrepresented groups, while also asking companies to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. 

Diversity & Inclusion Clinical Trials

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.

BIO Neurology

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.

FDA Clinical Trials

Amber Therapeutics Secures $100M To Develop Neuromodulation For Mixed Urinary Incontinence

UK-based Amber Therapeutics said it raised $100m in a series A financing round led by New Enterprise Associates. It plans to use the proceeds to fund the development of Amber-UI through pilot and pivotal studies aiming US regulatory approval.

Women's Health Financing

Carthera Aims To Break Barriers In Brain Cancer Treatment With BBB-Crossing Device

The France-based, clinical-stage medtech has enrolled first patients in a pivotal trial to evaluate overall survival in glioblastoma patients using its implanted SonoCloud-9 ultrasound device combined with a chemotherapy. If successful, it will become the first technology to optimize drug delivery by opening the blood-brain barrier.

Cancer Surgery

News We're Watching: ACLA Sues FDA; Philips Recall; New Funding In Women’s Health; FDA Nods

This week, the ACLA filed a lawsuit against the US FDA; Philips recalled around 100,000 ventilators; women’s health companies Natural Cycles and Gameto padded their coffers; and Canary Medical and J&J’s Ethicon received FDA nods.

News We're Watching Approvals

France Consults On Best Practice Guidelines For Decentralized Trials

The CNIL plans to update its data protection methodologies based mostly on the results of a new consultation and the outcome of a pilot in which companies are asked to identify the challenges they have faced when designing trials with decentralized elements.

Clinical Trials Guidance Documents

Industry Applauds AUD18.8m Funding For Australia’s ‘One Stop Shop’ For Clinical Trials

The plan is to create a single platform that would facilitate rapid and streamlined clinical trial approvals and address the challenges sponsors currently face in having to navigate different processes for clinical trials in each state and territory, and within area health services.

Australia Clinical Trials

AI Assisted Ablation Bests Conventional Procedure, Trial Data Shows

A study by French device firm Volta found an AI-guided ablation procedure was more effective in treating patients with atrial fibrillation, especially those whose symptoms had persisted for six months or longer.

Commercial Clinical Trials

News We’re Watching: Telehealth Advances; AI Regulation; NIH Backs SIRT; Oura Upgraded

This week, a House subcommittee advanced a two-year telehealth extension, Chuck Schumer and a bipartisan group of senators introduced a plan for regulating AI, the FDA launched its new online RST Catalog, NIH recommends targeted radiotherapy cancer treatment, and Oura announced new health features for its smart ring.

News We're Watching Artificial Intelligence

Mid-May MDCG Mandate Madness: Pre-empting Questions On Investigator Brochures

Newly issued EU guidance documents make it easier for device companies to draft clinical investigation brochures that will pass authority inspection. They also give insight into what notified body designating authorities check for.

Europe EU

EU Coordination Key To Speeding Up Combined Studies Of Drugs & IVDs/Devices

An EU project has proposed solutions to address key bottlenecks in the approval and conduct of studies that involve the simultaneous investigation of a medicinal product, an IVD and/or a medical device. 

Europe Clinical Trials

‘Mental Health, Beyond Medication’: Motif Targets Depression With Minimally Invasive DOT

Motif’s “pea-sized” Digitally programmable Over-brain Therapeutic (DOT) requires 20 minutes to implant and can be activated at home with a wearable to “lift the fog” for people with depression. Motif CEO Jacob Robinson believes data captured by brain-computer interfaces and continuous monitoring will eventually be able to identify key biomarkers that enable psychiatrists to head off mental health crises.

Behavioral Health Neurology
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