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Clinical Trials Day 2024 Recap: Celebrating Progress and Partnerships

XTalks

Clinical Trials Day is an opportunity to acknowledge the contributions of clinical researchers and participants and the advancements in medical science that improve patient outcomes worldwide. The FDA’s message emphasized the crucial advancements in science and technology that are propelling medicine forward.

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Magnus Medical’s SAINT Neuromodulation System Gets FDA Clearance to Treat MDD

XTalks

This week, Magnus Medical’s SAINT Neuromodulation System received 510(k) clearance from the US Food and Drug Administration (FDA) for the treatment of major depressive disorder (MDD) in adults who did not have satisfactory improvement from past antidepressant medications in their current episode. The SAINT Neuromodulation Trial.

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Four ways Biogen is tackling digital innovation in neurological disease

pharmaphorum

It can mean everything from patient-facing disease management apps and wearables to background AI dramatically altering drug discovery or radiological imaging. I believe the life sciences industry ecosystem is getting to be more familiar with digital health overall as a concept. About the interviewee.

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Considerations for Neuroscience Trials with Intrathecal Delivery and Other Methods of Direct CNS Administration

XTalks

According to an analysis of the 2013 Medical Expenditure Panel Survey, one in six US adults reported taking a psychiatric drug at least once in 2013. CNS drugs treat a range of neurologic and psychiatric disorders, such as psychosis, depression, Parkinson’s disease, multiple sclerosis and epilepsy.

Trials 83
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Abiomed’s Impella ECP; Helius’s PoNS Device; Smart Meter’s iGlucose BGM; XACT’s CT-Guided Percutaneous Procedures; BD’s Veritor At-Home COVID-19 Test; Delfi’s Liquid Biopsy

Delveinsight

On August 18, 2021, Abiomed received breakthrough device designation from the United States Food and Drug Administration (FDA) for its Impella ECP expandable percutaneous heart pump , the world’s smallest heart pump and the first to be compatible with small-bore access and closure techniques. Helius Medical Technologies, Inc.

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Packaging Solutions for Pharmaceuticals & Medical Devices: Insights and Considerations

XTalks

Container closure systems are highly regulated by health agencies. With a network including North America, Europe and Asia, Curia aims to improve patient outcomes and quality of life by offering a complete suite of solutions across its three divisions: Discovery, Development and Analytical (DDA), Drug Product and API Manufacturing.

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The Utility of Liquid Biopsy in Oncology Clinical Trials

XTalks

Immunofluorescent staining of CTCs is a CTC isolation method that has been used since the first US Food and Drug Administration (FDA) approval in 2013 for the CellSearch ® CTC enumeration platform. Regulators may ask at some point to provide that documentation, so it’s important to track that across the study.