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…Continue reading “FDA and cloud-based medical device”
Tag Archives: FDA
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 – FDAContinue reading “FDA and telehealth”
$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 ofContinue reading “$50k Humira drug costs per year in the USA”
Psychiatric medications and pharmacogenetic test
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 aContinue reading “What is pharmacogenetics?”
Examples of Mobile Apps For Which the FDA Will Exercise Enforcement Discretion
This list provides examples of mobile apps that MAY meet the definition of medical device but for which FDA intends to exercise enforcement discretion. These mobile apps may be intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease. Even though these mobile appsContinue reading “Examples of Mobile Apps For Which the FDA Will Exercise Enforcement Discretion”
A Few Ways the Government Shutdown Could Harm Your Health (And the World’s) by Maryn Mckeena
There’s going to be a lot — a lot — of coverage today on the federal shutdown, what it means and how long it might go on. I thought it might be worth quickly highlighting how it affects the parts of the government that readers here care most about: public health, global health, food safetyContinue reading “A Few Ways the Government Shutdown Could Harm Your Health (And the World’s) by Maryn Mckeena”
Caffeine can harm your body
Caffeine and Your Body Caffeine occurs naturally in more than 60 plants including coffee beans, tea leaves, kola nuts used to flavor soft drink colas, and cacao pods used to make chocolate products. Man-made caffeine is sometimes added to foods, drinks, and medicines. Ninety percent of people in the world use caffeine in one formContinue reading “Caffeine can harm your body”