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Prostate cancer: PSA screening does lower death risk, says review
A new review suggests that - contrary to current USPSTF guidelines - PSA screening significantly reduces the risk of death to prostate cancer.
FDA approves new antibacterial drug
The U.S. Food and Drug Administration has approved Vabomere for adults with complicated urinary tract infections (cUTI), including a type of kidney infection, pyelonephritis, caused by specific...
FDA approval brings first gene therapy to the United States
The U.S. Food and Drug Administration issued a historic action today making the first gene therapy available in the United States, ushering in a new approach to the treatment of cancer and other...
'Accelerated approval' drugs: How well are they studied?
When an investigational prescription drug shows promise for treating a serious illness or filling an unmet medical need, the Food and Drug Administration (FDA) has special programs available to...
FDA approves first treatment for certain types of poor-prognosis acute myeloid leukemia
The U.S. Food and Drug Administration has approved Vyxeos for the treatment of adults with two types of acute myeloid leukemia (AML): newly diagnosed therapy-related AML (t-AML) or AML with...
FDA approves new targeted treatment for relapsed or refractory acute myeloid leukemia
The U.S. Food and Drug Administration has approved Idhifa (enasidenib) for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) who have a specific genetic...
FDA approves Vosevi for Hepatitis C
The U.S. Food and Drug Administration has approved Vosevi to treat adults with chronic hepatitis C virus (HCV) genotypes 1-6 without cirrhosis (liver disease) or with mild cirrhosis.
FDA approves new treatment to reduce the risk of breast cancer returning
The U.S. Food and Drug Administration has approved Nerlynx (neratinib) for the extended adjuvant treatment of early-stage, HER2-positive breast cancer.
FDA approves new treatment for sickle cell disease
First approval for this rare blood disorder in nearly 20 years.The U.S. Food and Drug Administration has approved Endari (L-glutamine oral powder) for patients age five years and older with...
FDA clears expanded use of cooling cap to reduce hair loss during chemotherapy
The U.S. Food and Drug Administration has cleared the expanded use of a cooling cap, DigniCap Cooling System, to reduce hair loss (alopecia) during chemotherapy.
Cosmetic complaints climb but products still on market
Study highlights poor reporting to the FDA of potentially harmful cosmetic products and calls for better data along with policy changes.
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?
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