Pharma Medical News about Device Approval

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Developing medical device technologies from users perspectives: A theoretical framework for involving users in the development process
International Journal of Technology Assessment in Health Care, 11/05/09

Shah SGS et al. – Development of medical devices from users’ perspectives requires not only the involvement of healthcare professionals but also that of the ultimate end users, that is, patients, people with disabilities and/or special needs, and their caregivers. The evidence shows that such end users quickly discard devices that do not fulfill their personal expectations, even though both manufacturers and healthcare professionals may consider those end users’ requirements met.

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CryoLife Receives Humanitarian Use Device Designation for SynerGraft(R) Processed Human Aortic Heart Valves
Cryolife, 10/07/09 Relevance Score: 68%

Novartis biological drug Ilaris approved in EU to treat children and adults with CAPS, a rare debilitating auto-inflammatory disease
Novartis, 10/29/09 Relevance Score: 67%

CryoLife Receives FDA Approval to Begin U.S. Clinical Trial for BioFoam
Cryolife, 10/28/09 Relevance Score: 67%

Anti-Malignancy Agent/Anti-VEGF Humanized Monoclonal Antibody, Avastin Application for Approval of Additional Indication of Breast Cancer
Chugai Pharmaceutical Co., 10/19/09 Relevance Score: 67%

U.S. Food and Drug Administration approves CRESTOR for use in pediatric patients with heterozygous familial hypercholesterolemia
AstraZeneca, 10/19/09 Relevance Score: 67%