Sunshine Heart has submitted an investigational device exemption (IDE) application of its C-Pulse Heart Assist system to the US Food and Drug Administration (FDA) for approval. The basis of the IDE application is for the initiation of ...
Tags: FDA, medical system, medical technology
ClearCorrect has entered into a collaboration agreement to integrate Objet's 3D printing systems as part of its mass-scale manufacturing of orthodontic aligners. Under the agreement, ClearCorrect will use 3D printing systems to ...
Sunshine Heart is planning to initiate a US pivotal trial on its C-Pulse Heart Assist device in the fourth quarter of 2012, as it received an unconditional approval from the US Food Drug Administration (FDA). The CE marked system, ...
Tags: FDA, clinical trial, medical system
A new clinical study found that Bayer's blood glucose monitoring (BGM) system CONTOUR Next EZ meter and CONTOUR Next test strips proved easy to use and highly accurate when used by both patients and their healthcare professionals (HCPs). ...
Tags: medical system, clinical trial, blood glucose monitoring system
OncoSec Medical has obtained CE certification for its proprietary gene and drug delivery technology, designed to treat solid tumor cancers. The assessment and certification process was supervised by SGS Group, a provider of inspection, ...
Tags: OncoSec, CE certification, proprietary gene, drug delivery technology
OncoSec Medical has obtained ISO 13485 quality management system (QMS) certification for the design, development, manufacture, and distribution of its electroporation device including the OncoSec medical system (OMS). Currently being used ...
Tags: OncoSec Medical, OncoSec medical system, OMS
Viztek has launched Opal-Mammo integrated mammography suite that combines PACS and tracking software. The system is built on a platform which consists of intuitive controls that require minimal training to operate. Viztek sales ...
Sapheon, a developer of technologies for the treatment of vascular diseases, has completed the first closing in its $18.5m Series B Preferred equity offering. The company said the proceeds from the Series B offering will be used to ...