Liquid-in-liquid printing method could be used for bioprinting organs

Liquid-in-liquid 3D printing was first presented in a BMW funded MIT project. Although the project initially seemed limited in scope the possibilities of 3D printing within a liquid medium opens new opportunities in terms of escaping gravitational pull and thus producing parts that require a more volumetric approach, such as biological structures and organs. As reported

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Another step forward in digital health: FDA issues draft guidance for drug master files (DMFs) for electronics and software components of combination products regulated primarily as a drug

On Monday, the FDA published the draft guidance, “Type V DMFs for CDER-Led Combination Products Using Device Constituent Parts With Electronics or Software,” which could facilitate drug manufacturers’ ability to integrate digital health tools which are regulated as medical devices.  The guidance describes when a Type V drug master file (DMF) can be used to provide

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Living Skin Can Now be 3D-Printed With Blood Vessels Included

Development is significant step toward skin grafts that can be integrated into patient’s skin Researchers at Rensselaer Polytechnic Institute have developed a way to 3D print living skin, complete with blood vessels. The advancement, published online today in Tissue Engineering Part A, is a significant step toward creating grafts that are more like the skin our bodies

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Assessment of Accuracy of an Artificial Intelligence Algorithm to Detect Melanoma in Images of Skin Lesions

Source JAMA Network Open IMPORTANCE A high proportion of suspicious pigmented skin lesions referred for investigation are benign. Techniques to improve the accuracy of melanoma diagnoses throughout the patient pathway are needed to reduce the pressure on secondary care and pathology services. OBJECTIVE To determine the accuracy of an artificial intelligence algorithm in identifying melanoma

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Novel deep-learning approach for predicting and explaining the key prognostic factors for patients with Mesothelioma

Owkin publishes breakthrough research in Nature Medicine Owkin, which is developing machine learning technologies to advance medical research, today announces publication of a paper in Nature Medicine that showcases its breakthrough analysis of tumour biology using interpretable deep-learning models. The paper entitled ‘Deep learning-based classification of mesothelioma improves prediction of patient outcomes’ describes how Owkin

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FDA Updates Digital Health Guidances to Align with 21st Century Cures Act

Source https://www.mintz.com/insights-center/viewpoints/2791/2019-10-fda-updates-digital-health-guidances-align-21st-century On September 26, 2019, FDA released a suite of revised digital health guidances, which includes the following: Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act (“Section 3060 Changes Guidance”) – Final Policy for Device Software Functions and Mobile Medical Applications (“MMA Guidance”) – Final General Wellness: Policy for

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3D Bioprinting of Living Tissues

3D-printed thick vascularized tissue constructs for organ engineering and regenerative medicine In this video, the Wyss Institute and Harvard SEAS team uses a customizable 3D bioprinting method to build a thick vascularized tissue structure comprising human stem cells, collective matrix, and blood vessel endothelial cells. Their work sets the stage for advancement of tissue replacement

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