Glysure CEO Discusses Real-Time Glucose Monitoring Technology, ISO 13485 Certification and CE Mark

As part of our expert series on the state of the industry, OneMedRadio spoke with Glysure CEO Chris Jones to discuss this recent news and learn about this unique technology. Jones also discussed trends in the industry affecting company growth and investment strategy, including reimbursement issues, evolving exit strategy, and the move away from normative medicine.

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RELEASE: Glysure Earns ISO 13485 Certification

GlySure Limited, developer of in-hospital continuous blood glucose monitoring systems, today announced that it has achieved ISO 13485 certification, the global standard for the requirements of a quality management system for the design, manufacture and distribution of medical devices. By establishing a quality management system that meets international regulatory and customer requirements, GlySure has set the foundation for its European clinical trials.

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MediTech Strategic Consultants B.V.: European Medical Devices Market Authorization (CE MARK)

MediTech Strategic Consultants B.V. (MediTech) is full service European Contract Research Organization (CRO) specializing in medical devices and combination products focused on Clinical, Regulatory and Quality consulting as well as Authorized Representative Services.

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Neovasc’s Refractory Angina Treatment Receives CE Mark

Results of a published prospective three-year clinical study have demonstrated that the Reducer is safe and effective at providing relief of angina symptoms in refractory angina patients.

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Navigating the Perilous Road: A Special Panel On Regulatory and Reimbursement Issues

A panel at OneMedForum NY 2011 will explore strategic planning considerations in the process of getting approval and reimbursement.

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EnteroMedics Gets CE Mark For Anti-Obesity Device

EnteroMedics received the European CE Mark Certification for the Maestro RC System, the St. Paul, Minnesota company announced.

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