Clinical / R & D
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Clinical Trials
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New UAE Regulator Calls On Drug and Device Companies To Help Shape Mandate
Facilitating and strengthening R&D, intellectual property rights protection and drug safety are among the goals of the soon-to-be-launched Emirates Drug Establishment. Despite the name, the entity is also responsible for device regulation.
Sex-Based Diversity In Clinical Trials Can And Will Improve – An IWD Perspective
As a three-time cancer survivor and someone who has participated in a device trial, Alicia Staley, Medidata’s VP of patient engagement, is no stranger to innovative treatments. She spoke to Medtech Insight about how both the gender and socioeconomic diversity of trial participants could be improved.
Identifying The Barriers To Digital Clinical Trial Technologies
Digital clinical trials, a trend sparked by the COVID-19 pandemic that has held the biopharma industry’s interest, are changing the way patients interact with research and improving access, says Medable’s CEO.
Cardio Conversations: ‘Much More Than Just A Patch,’ iRhythm CEO Blackford Talks AI Arrhythmia Diagnostics
iRhythm CEO Quentin Blackford returned to Medtech Insight’s Cardio Conversations podcast to talk about the launch of his company’s new Zio monitor patch supported by a sophisticated neural network. He also addressed the company’s plans to improve its position in the mobile cardiac telemetry market, the impact of pulsed field ablation on the cardiac monitoring business, and more.
New Technology
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Artificial Intelligence: US FDA Plans Guidances On Algorithm Bias, Product Development
Cross-center AI strategy features collaboration between drug, biologic, device and combination product staff to ensure regulatory predictability. ‘Assurance labs’ offering independent valuation of models should be available by year-end as part of FDA’s involvement with Coalition for Health AI.
New UAE Regulator Calls On Drug and Device Companies To Help Shape Mandate
Facilitating and strengthening R&D, intellectual property rights protection and drug safety are among the goals of the soon-to-be-launched Emirates Drug Establishment. Despite the name, the entity is also responsible for device regulation.
Healthtech Responds To Providers’ Productivity, Workflow And Sustainability Concerns
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.
Global Regulators Home In On Regulatory Reliance, Propose Universal Framework
Regulatory reliance was the theme on Day one of the 25th Management Committee of the International Medical Device Regulators Forum in DC, with regulators from across the globe touching on the need for clarity, consistency, and trust among the world’s various regulatory bodies. The attendance for this year’s meeting was largest in the history, with some 1,200 guests representing more than 60 countries and 550 public and private sector organizations.
Approvals
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New UAE Regulator Calls On Drug and Device Companies To Help Shape Mandate
Facilitating and strengthening R&D, intellectual property rights protection and drug safety are among the goals of the soon-to-be-launched Emirates Drug Establishment. Despite the name, the entity is also responsible for device regulation.
News We’re Watching: FDA Approves Medtronic's Affera, Roche's CGM Moves Closer To Approval, And More
Medtech Insight's News We're Watching covers medtech industry and research news you may have missed. This week, the Advanced Technologies and Treatments for Diabetes (ATTD) conference in Florence, Italy, included new results from studies of Roche's continuous glucose monitor and Medtronic's 780G insulin pump, Medtronic moved closer to earning FDA approval for its Affera ablation mapping and ablation system, and Linus Health expanded its technology for finding signs of cognitive problems in speech data.
News We’re Watching: First OTC Blood Glucose Monitor, Recalls For Ventec and Medtronic, Guidance Docs Under White House Review
This week, the US FDA announced that it had cleared Dexcom’s Stelo Glucose Biosensor System, making it the first OTC device of its type available in the US. Additionally, the Office of Management and Budget took up guidance documents on cybersecurity and enforcement on diagnostics during emergencies, and recalls were announced by Medtronic, Ventec and Cardinal.
Dexcom CEO Talks Stelo Launch, Broader Plans, And GLP1 Misconceptions
Medtech Insight spoke to Dexcom CEO Kevin Sayer, ahead of this year’s Advanced Technologies & Treatments for Diabetes conference, to get an update on the company’s recent news, future strategy and where he feels his company’s market is headed.
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