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Total 3 results found since Jan 2013.
Janssen Submits Application to U.S. FDA for New Indication to Expand Use of XARELTO ® (rivaroxaban) in Patients with Peripheral Artery Disease
RARITAN, NJ, October 26, 2020 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today it has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for a new indication to expand the use of XARELTO® (rivaroxaban) in patients with peripheral artery disease (PAD). If approved, this new indication for the XARELTO® vascular dose (2.5 mg twice daily plus aspirin 75-100 mg once daily) would include reducing the risk of major thrombotic vascular events such as heart attack, stroke and amputation in patients after recent lower-extremity revascularization, a c...
Source: Johnson and Johnson - October 26, 2020 Category: Pharmaceuticals Tags: Innovation Source Type: news
Developing a New Score: How Machine Learning Improves Risk Prediction
Composite risk scores have been used for decades to identify disease risk and health status in the general population. However, current approaches often fail to identify people who would benefit from intervention or recommend unnecessary intervention. Machine learning promises to improve accuracy, ensuring targeted treatment for patients that need it and reducing unnecessary intervention.
Framingham Risk Score, the gold standard for predicting the likelihood of heart disease, predicts hospitalizations with about 56% accuracy. It uses factors such as age, gender, smoking, cholesterol levels, and systolic blood pressure to...
Source: MDDI - November 17, 2017 Category: Medical Devices Authors: Heather R. Johnson Tags: R & D Source Type: news
What ’s the Big Deal about Data in Medtech?
Discussion, “Top 5 Things You Need to Know about the Implantable Internet of Things."
Brian Chapman, partner and leader of ZS’s medtech practice of ZS, attributes today’s focus on data to the intersection of two important things:
"A general recognition that understanding more and connecting actions with outcomes will provide feedback and understanding that will drive standards of care. This is not new, but as capabilities rise in data collection, aggregation, and synthesize rise, and coupled with machine learning, the promise of data in healthcare is becoming even more ...
Source: MDDI - December 20, 2019 Category: Medical Devices Authors: Daphne Allen Tags: Digital Health Source Type: news
