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ABM Respiratory Care Announces the FDA Clearance of the Biwaze Clear System

Legacy MEDSearch

Food and Drug Administration (FDA) 510(k) clearance of the BiWaze ® Clear System. Founded in 2017, ABM Respiratory Care is dedicated to advancing patient care by developing intelligent, clinically differentiated and innovative respiratory care solutions to help people breathe better inside and outside the hospital.

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Lumendi Receives 510(k) Clearance for Two New Devices

Legacy MEDSearch

Food and Drug Administration (FDA) 510(k) clearance for DiLumen EZ¹, a single-use, disposable endotherapy device for endoscopic mucosal resections (EMR) and difficult colonoscopies. Since 2017, clinicians in the U.S., Connecticut-based medical device innovator Lumendi, LLC announced that it has received U.S.

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SpectraWAVE Secures 510(k) Clearance of HyperVue™ Intravascular Imaging System

Legacy MEDSearch

a medical imaging company focused on improving the treatment and outcomes for patients with coronary artery disease (CAD), today announced Food and Drug Administration (FDA) 510(k) clearance of their flagship intravascular imaging system, HyperVue. SpectraWAVE, Inc., About SpectraWAVE, Inc. million adults age 20 and older.

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The potential of tryptamines in treatment-resistant depression

European Pharmaceutical Review

Compared to conventional antidepressant therapy that consists of daily oral administration, psilocybin therapy acts through a single-dose capsule, with repeated administration being investigated in COMPASS’ larger Phase III study. Homological scaffolds of brain functional networks Journal of the Royal Society Interface.

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Pharma within planetary boundaries

European Pharmaceutical Review

In addition, the number of active substances detected in the environment has been increasing with unknown consequences for ecosystems and the accumulation of substances in food chains. Therefore, another question is how we can obtain reliable, transparent information on older drugs.

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Untapped opportunity: the growing potential of clinical trials in Georgia

Pharmaceutical Technology

This will put up a barrier to the traditional system where the drugs are shipped on a direct-to-site basis straight away from the manufacturing facilities to a Georgia storage facility within the location.”. In 2017 Oximio began providing dedicated local clinical trial support from its depot in Tbilisi as well as its courier fleet.

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Ceribell Receives FDA 510(k) Clearance and CMS NTAP Reimbursement for New ClarityPro™ Software with Electrographic Status Epilepticus Diagnostic Indication

Legacy MEDSearch

Food and Drug Administration (FDA) for the indication of diagnosing Electrographic Status Epilepticus (ESE).  The Ceribell EEG System first received FDA 510(k) clearance in 2017 and is commercially available in the United States. Ceribell, Inc.

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