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FDA Launches Digital Health Unit – Medpage Today

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The FDA’s Center for Devices and Radiological Health is ramping up medical app and device offerings with a recently announced digital health unit.

The aim of this development is to centralize and coordinate digital health information so that there is consistency in applying policies. According to the associate director of digital health for the FDA, Bakul Patel, the primary responsibilities of those on the project will be to develop software and digital health tech to assist with premarket submissions or devices, utilize experts, and incorporate metrics that will aid review times and submissions.

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Biotech close to diabetes breakthrough – Innovators magazine

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A vaccine that could provide a major breakthrough in the fight against Type 1 diabetes is to be tested in human trials.

Developed by Belgian biotech Imcyse, in collaboration with the French National Institute of Health and Medical Research (INSERM) in Paris – and 18 clinical sites across Europe, the company’s Imotopes™ technology can destroy immune cells that kill insulin-producing cells.

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7 Reasons To Join Business Incubators – HuffPost

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As an entrepreneur, I spent over three years in two different startup incubators – Brazil’s Genesis Institute, part of PUC-Rio’s university, and Maryland’s Rockville Innovation Center, run by Montgomery County’s Economic Development Department. As mentor, I have also had the opportunity to coach several incubated companies, from incubators like 1776 and beyond. I could experience firsthand the benefits of business incubation, which can be significant for early-stage entrepreneurs.

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Lumina kicks venture capital arm into high gear – Indianapolis Business Journal

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For more than a decade, Indianapolis-based Lumina Foundation has been making grants to organizations that support its mission of increasing the number of adults obtaining postsecondary credentials.

That’s the typical playbook for private foundations—contribute to other not-for-profits that are trying to make a difference. But over the past year, Lumina has aggressively moved in a more novel direction, funneling more of its $1.2 billion endowment into venture capital. Instead of just handing out grants, it’s taking ownership stakes in for-profit businesses, mainly education-tech startups.

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University Of Maryland, Baltimore And Serenta Team Up To Fight Staph Infections

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University of Maryland (UM) Ventures announced today that the University of Maryland, Baltimore (UMB) has granted worldwide, exclusive licensing rights for a new vaccine technology to Serenta Biotechnology, LLC, a Gaithersburg, MD-based startup. The license is based on technology co-owned by UMB and Northern Arizona University and is the basis for a multivalent vaccine against infections caused by Staphylococcus aureus, a bacterial strain often resistant to antibiotics.

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