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New study exposes major flaws in US drugs with 'accelerated' approval
A new study has exposed major flaws in the fast tracking of some drugs available to the American public without any stringent clinical evidence of their benefits.
FDA approves first generic Strattera for the treatment of ADHD
The U.S. Food and Drug Administration has approved the first generic versions of Strattera (atomoxetine) to treat attention-deficit/hyperactivity disorder (ADHD) in pediatric and adult patients.
FDA approves first cancer treatment for any solid tumor with a specific genetic feature
The U.S. Food and Drug Administration has granted accelerated approval to a treatment for patients whose cancers have a specific genetic feature (biomarker).
Nearly 1 in 3 drugs found to have safety concerns after FDA approval
How often are safety concerns raised about a drug after it's been approved by the FDA?
FDA approves new combination treatment for acute myeloid leukemia
The U.S. Food and Drug Administration has approved Rydapt (midostaurin) for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) who have a specific genetic mutation...
FDA approves first treatment for a form of Batten disease
The U.S. Food and Drug Administration has approved Brineura (cerliponase alfa) as a treatment for a specific form of Batten disease.
FDA expands approved use of Stivarga to treat liver cancer
The U.S. Food and Drug Administration has expanded the approved use of Stivarga (regorafinib) to include treatment of patients with hepatocellular carcinoma (HCC or liver cancer) who have been...
Medical marijuana laws linked to greater increase in illicit use, disorders
A new study published in JAMA Psychiatry finds that states with medical marijuana laws have seen a higher increase in illicit marijuana use and disorders.
FDA approves first drug to treat tardive dyskinesia
The U.S. Food and Drug Administration has approved Ingrezza (valbenazine) capsules to treat adults with tardive dyskinesia. This is the first drug approved by the FDA for this condition.
FDA approves two hepatitis C drugs for pediatric patients
The U.S. Food and Drug Administration has approved supplemental applications for Sovaldi (sofosbuvir) and Harvoni (ledipasvir and sofosbuvir) to treat hepatitis C virus (HCV) in children ages 12 to...
FDA allows marketing of first direct-to-consumer tests that provide genetic risk information for certain conditions
The U.S. Food and Drug Administration has allowed marketing of 23andMe Personal Genome Service Genetic Health Risk (GHR) tests for 10 diseases or conditions.
FDA approves drugs more quickly than peer agency in Europe
The U.S. Food and Drug Administration (FDA) reviews and approves new medicines in a shorter timeframe than its peer agency in Europe, the European Medicines Agency (EMA), says a Yale researcher.
The war on tobacco: Latest estimates show need for 'renewed and sustained' efforts on control policies
More than one in 10 deaths worldwide (equivalent to 6.4 million deaths) are caused by smoking and half of these occur in just four countries - China, India, USA, and Russia, according to the latest...
FDA approves new drug to treat multiple sclerosis
The U.S. Food and Drug Administration has approved Ocrevus (ocrelizumab) to treat adult patients with relapsing forms of multiple sclerosis (MS) and primary progressive multiple sclerosis (PPMS).
FDA approves new eczema drug Dupixent
The U.S. Food and Drug Administration has approved Dupixent (dupilumab) injection to treat adults with moderate-to-severe eczema (atopic dermatitis).
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