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Power to the Patient with Patient Generated Health Data

FDA Law Blog

Lenz, Principal Medical Device Regulation Expert — FDA’s Center for Devices and Radiological Health (CDRH) recently partnered with the Digital Medicine Society (DiMe) to host a two-day workshop to help advance the use of patient-generated health data (PGHD) to support improved clinical trials, medical device development, and regulatory science.

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MIOTIFY platform for digital health products clears AZ road test

pharmaphorum

The Compliant Component Builder platform has already been put through its paces at AstraZeneca, which used it to build a new component to incorporate into one of its existing digital health tools, used for remote monitoring of patients in clinical trials. The algorithms used in healthcare are becoming more complex as well.

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AstraZeneca’s COVID-19 vaccine; Type 1 diabetes research updates; FDA nod to Zebra’s X-ray modelling AI; UniQure/CSL haemophilia B gene therapy curbs bleeding in phase 3

Delveinsight

In a pooled analysis of 11,636 participants enrolled in two separate clinical trials in the U.K. trial came to give some subjects a half-dose primer and offers potential explanations for the effect but omits the key question of whether the regimen has 90% efficacy or not. The Lancet paper offers background on how the U.K.

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Top 10 Medical Device Companies in 2023 by Revenue Statistics and Trends

XTalks

Medtronic’s proactive stance towards R&D is evident from the over 230 clinical trials it conducted and the more than 200 regulatory approvals it received in the US, Europe, Japan and China in the 2022 fiscal year. Internationally, Medtronic expanded its MiniMed 780G insulin pump and Guardian 4 sensor.

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Addressing Screen Failures in MASH Clinical Trials: Strategies for Success

Worldwide Clinical Trials

Metabolic dysfunction-associated steatohepatitis (MASH) presents a complex challenge in clinical trials due to its multifaceted nature and requirements for proper diagnosis. At Worldwide Clinical Trials, were committed to leveraging our MASH experience and patient-centric approach to navigate these challenges and drive better outcomes.