Tag: FDA

FDA and cloud-based medical device

Digital Health Criteria – FDA https://www.fda.gov/MedicalDevices/DigitalHealth/ucm575766.htm Sep 22, 2017 – Software run on a hardware medical device is a SaMD when not part of the intended use of the hardware medical device. … A picture archiving and communications system consists of cloud–based, web-accessible software that analyzes cardiovascular images acquired from magnetic resonance (MR) … Medical Device Data Systems – FDA https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/GeneralHospital…

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FDA and telehealth

Digital Health – FDA https://www.fda.gov/medicaldevices/digitalhealth/ Dec 7, 2017 – The broad scope of digital health includes categories such as mobile health (mHealth), health information technology (IT), wearable devices, telehealth and telemedicine, and personalized medicine. Providers and other stakeholders are using digital health in their efforts to: Reduce inefficiencies,; Improve … ‎Guidances with Digital Health … · ‎Mobile Medical Applications · ‎(Pre-Cert) Program Mobile Medical Applications – FDA

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$50k Humira drug costs per year in the USA

Adalimumab (trade names Humira and Exemptia) is a medication used for rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, moderate to severe chronic psoriasis, moderate to severe hidradenitis suppurativa, and juvenile idiopathic arthritis. In rheumatoid arthritis, adalimumab has a response rate similar to methotrexate, and in combination nearly doubles the response rate of

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What is pharmacogenetics?

Overview: What is pharmacogenetics? Some of us respond differently than others to the same medications that we take, or we may experience different side-effects from drugs. The way we respond can be due to the genes we have inherited. With respect to drugs, our unique genetic make-up and our individual response may mean that a

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