Cardiovascular Systems has completed enrolling 443 patients in the ORBIT II trial of its electric orbital atherectomy system(OAS),designed to treat severe calcified coronary arteries. The first premarket approval(PMA)trial,which is ...
Tags: cardiovascular system, OAS, severe calcified coronary arteries, ORBIT II
The US Food and Drug Administration (FDA) has granted approval to Cohera Medical's first module of its premarket approval (PMA) application for an internal surgical adhesive. The CE marked internal adhesive, TissuGlu, is designed for ...
Tags: internal surgical adhesive, adhesive, Medical's module
Dune Medical Devices has obtained an approvable letter related to its premarket approval application (PMA) for the breast cancer detection system from the US Food and Drug Administration (FDA). The letter indicates that the system's PMA ...
GI Dynamics has gained full approval to initiate ENDO trial for its non-surgical EndoBarrier device from the US Food and Drug Administration (FDA). The EndoBarrier liner, which is implanted into the gut, is a flexible, tube-shaped device ...
Tags: ENDO trial, non-surgical EndoBarrier device, EndoBarrier liner
Cytori Therapeutics has treated first US patient in the ATHENA trial using the company's cell therapy based on patient's own adipose-derived stem and regenerative cells (ADRCs). ADRCs are processed using the company's proprietary Celution ...
The Ovation network and design expert Lisa S.Roberts will collaborate on a reality television show entitled"My Design Life,"which will premiere with two back-to-back episodes on the Ovation network on August 24,at 8:00 pm ET/PT.The show ...
Tags: Graphic Design, Reality Television Show, Art
The US Food and Drug Administration (FDA) has granted premarket approval (PMA) to Roche's new fully automated COBAS AmpliPrep / COBAS TaqMan CMV test to quantify cytomegalovirus' (CMV) DNA in human plasma specimens. The real-time ...
Tags: Roche, FDA, Viral Load Test, PCR-based CMV test
The US Food and Drug Administration (FDA) has granted premarket approval (PMA) to Beckman Coulter's simple, non-invasive Prostate Health Index (phi) blood test. The phi test, indicated for use in men with a prostate-specific antigen (PSA) ...
Tags: phi blood test, Prostate Health Index Test, immunoassay systems
Italian packaging machinery manufacturer Sacmi has developed a new PMA24L that inserts “PVC-free” liners in metal caps. The latest innovation is called PMA24L – acronym for “Plasmatic for metal for ring-shaped liners ...
Tags: packaging machinery