Clinical Trials
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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In what could amount to a de facto enforcement mechanism, the new draft guidance also “strongly encourages” sponsors to share details about their diversity action plan and enrollment goals with the public.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 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New draft guidance on clinical trial diversity action plans pushes for disproportionately high enrollment of traditionally underrepresented groups, while also asking companies to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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
‘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.
Egypt’s First Decentralized Trials Guideline Addresses Using Off-Site Nurses
Drawing references from the EU and US guidelines for decentralized clinical trials, the Egyptian FDA has framed draft requirements that sponsors should consider when planning to use off-site nurses in their drug and medical device studies.
GlucoTrack’s CEO Wants To ‘Keep Pushing The Boundaries’ With Implantable CGM
CGM company GlucoTrack Inc. recently announced plans to expand measuring glucose into the spinal epidural space for patients with painful diabetic neuropathy and its new computational data to support sensor longevity beyond three years from currently two years. Medtech Insight spoke with GlucoTrack’s CEO, Paul Goode, about the company's ambitions to offer more choice in glucose monitoring to people with diabetes.
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