FDA Takes New Steps to Advance Digital Health, Opening Docket to Solicit Feedback on Software Products
Today, the FDA is opening a docket to solicit feedback on important provisions of the 21st Century Cures Act ("Cures Act"). The Cures Act amended the Federal Food, Drug, and Cosmetic Act to exclude certain medical software functions from the definition of a medical device. Under the Cures Act, Congress excluded specific types of software from FDA regulation, including general wellness software products, electronic patient records and more.
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International Master's in Medical Informatics at the Heart of Europe
The Master of Science Program in Medical Informatics (MMI) at European Campus Rottal-Inn (ECRI) in Pfarrkirchen - a branch of the Deggendorf University of Applied Sciences (THD - Technische Hochschule Deggendorf) in Bavaria, Germany - is accepting applications for entry in October 2018.
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Applications for the G4A Global Accelerator Are Now Open
Founded in 2013 in Berlin initially giving out grants to innovative healthcare apps, G4A Accelerator is now a global program dedicated to helping innovative health & care startups grow and enable positive disruption and progress within the digital health & care universe.
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Novartis Launches FocalView App, Providing Opportunity for Patients to Participate in Ophthalmology Clinical Trials from Home
Novartis announced the launch of its FocalView app, an ophthalmic digital research platform created with ResearchKit. FocalView aims to allow researchers to track disease progression by collecting real-time, self-reported data directly from consenting patients. By adapting the design of clinical trials to suit the daily routine of patients, the app may reduce barriers to participation, leading to a more nuanced understanding of ophthalmic diseases and potentially accelerating the development of novel treatments.
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FDA Permits Marketing of Artificial Intelligence-Based Device to Detect Certain Diabetes-Related Eye Problems
The U.S. Food and Drug Administration today permitted marketing of the first medical device to use artificial intelligence to detect greater than a mild level of the eye disease diabetic retinopathy in adults who have diabetes. Diabetic retinopathy occurs when high levels of blood sugar lead to damage in the blood vessels of the retina, the light-sensitive tissue in the back of the eye.
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Pitch for Smarter Healthcare at the Roche Innovation Summit
The European Innovation Council (EIC) SME Instrument and Roche invite you to pitch your ideas and breakthroughs on healthcare tech at the Roche Innovation Summit on the 19th and 20th of June in Basel, Switzerland. On a yearly basis, Roche organises an internal Innovation summit, to inspire, connect, develop and advance their organisation.
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Merck Partners with Medisafe to Help Improve Medication Adherence for Cardiometabolic Patients
Merck, a leading science and technology company, today announced a new collaboration with US-based Medisafe to help its cardiometabolic patients better manage medication intake and adhere to prescribed treatment regimens. In the countries of scope Merck patients will have access to a customized version of Medisafe's mobile platform that could combine reminders, motivation and support systems, targeted content, coupons and interventions in their local language.
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Today, the FDA is opening a docket to solicit feedback on important provisions of the 21st Century Cures Act ("Cures Act"). The Cures Act amended the Federal Food, Drug, and Cosmetic Act to exclude certain medical software functions from the definition of a medical device. Under the Cures Act, Congress excluded specific types of software from FDA regulation, including general wellness software products, electronic patient records and more. 
Novartis announced the launch of its FocalView app, an ophthalmic digital research platform created with ResearchKit. FocalView aims to allow researchers to track disease progression by collecting real-time, self-reported data directly from consenting patients. By adapting the design of clinical trials to suit the daily routine of patients, the app may reduce barriers to participation, leading to a more nuanced understanding of ophthalmic diseases and potentially accelerating the development of novel treatments. 
The European Innovation Council (EIC) SME Instrument and Roche invite you to pitch your ideas and breakthroughs on healthcare tech at the Roche Innovation Summit on the 19th and 20th of June in Basel, Switzerland. On a yearly basis, Roche organises an internal Innovation summit, to inspire, connect, develop and advance their organisation. 
Merck, a leading science and technology company, today announced a new collaboration with US-based Medisafe to help its cardiometabolic patients better manage medication intake and adhere to prescribed treatment regimens. In the countries of scope Merck patients will have access to a customized version of Medisafe's mobile platform that could combine reminders, motivation and support systems, targeted content, coupons and interventions in their local language.