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FDA Approves Innovative 4D Flow MRI Blood Flow Analysis Software from Cardio Flow Design Inc.

Legacy MEDSearch

The FDA approval is significant as it recognizes the safety and effectiveness of iTFlow® in analyzing blood flow through 4D Flow MRI data, with the potential to enhance diagnostic accuracy for patients with cardiovascular diseases and heart conditions. iTFlow® is an innovative software solution developed by Cardio Flow Design Inc.

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Refillable Device for Drug Delivery Past the Blood-Brain Barrier: Interview with Mike Maglin, CEO at CraniUS

Medgadget

This layer of specialized endothelium significantly restricts which drug molecules can enter the brain, normally greatly limiting treatment options for patients with brain-based disease. CraniUS , a medtech company based in Baltimore, has developed the NeuroPASS drug delivery system.

Medicine 106
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eCential Robotics Receives FDA Clearance for its Surgical Robotic Platform for Spine Surgery

Legacy MEDSearch

eCential Robotics, a French growth MedTech company that designs and produces a system unifying 2D/3D imaging, surgical navigation and robotics, announced FDA 510(k) clearance of its 3D imaging, navigation and robotics guidance system, securing the penetration of its unified robotic platform in the United States. Securing the U.S.

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Shear-Thinning Biomaterial for Embolic Applications: Interview with Upma Sharma, President and CEO of Arsenal Medical

Medgadget

The market’s current leading liquid embolic contains a solvent, dimethyl sulfoxide (DMSO), which can cause pain upon injection, necessitating the use of anesthesia and special compatible catheters. Medgadget: Does the material require a specialized delivery device? How is it delivered, and how do you prevent device blockage?

Medical 69
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GAMP 5 update: computerized system expectations for pharma manufacturers

European Pharmaceutical Review

The validation of computerized systems should be focused on ‘intended use’ and scaled commensurate with the risks to patient safety, product quality and data integrity” The focus until now has too often been on compliance and not on quality. Takeaways from ISPE’s GAMP 5 Second Edition update.

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Taking advantage of protein charge properties for challenging separations

European Pharmaceutical Review

The removal/separation of impurities and ensuring the purity of biologics is essential to the safety and quality of the therapeutic. She has expertise in protein separations with special emphasis on the importance of protein interactions with surrounding surfaces and the role they play on the separation.

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The Latest Biotech Trends of 2022

Impetus Digital

Recently, there have been some exciting advances in this area of research; Cabois, a company specializing in the production of biofuels and biochemicals, announced the opening of its first plant dedicated to breaking down polyethylene terephthalate (PET). It used to take years for a drug to progress from laboratory research to FDA approval.