BioDelivery Sciences International (BSDI) announced that it engaged in a positive meeting with the US Food and Drug Administration (FDA) regarding the clinical development program for Clonidine topical gel that will allow the program to ...
The US Food and Drug Administration (FDA) has granted orphan drug designation to Conatus Pharmaceuticals' drug candidate emricasan for the treatment of liver transplant patients with reestablished fibrosis to delay the progression to ...
Fujifilm Medical Systems U.S.A., a provider diagnostic imaging products and medical informatics solutions, has obtained 510(k) approval from the US Food and Drug Administration (FDA) for its Gadolinium and Cesium digital X-ray detectors for ...
Germany-based TomTec Imaging Systems has obtained 510(k) clearance from the US Food and Drug Administration (FDA) for its TomTec-Arena 1.0 software solution. TomTec-Arena 1.0 is the newest addition to the company's product portfolio. ...
US-based Claret Medical has submitted an investigational device exemption (IDE) application to the US Food and Drug Administration (FDA) for a multicenter study of the company's Sentinel cerebral protection system (CPS) for embolic ...
W. L. Gore & Associates, Inc. (Gore) has received Shonin approval from the Japanese Ministry of Health, Labor and Welfare to market the GORE EXCLUDER AAA endoprosthesis featuring C3 Delivery System as a minimally invasive treatment for ...
NEC Display Solutions of America has obtained 510(k) clearance from the US Food and Drug Administration (FDA) for its 24-inch MultiSync MD242C2 widescreen display for diagnostic review applications in healthcare organizations. MultiSync ...
Royal Philips has introduced its Vereos PET/CT fully digital positron emission tomography/computed tomography (PET/CT) imaging system and its IQon Spectral CT spectral detector-based computed tomography (CT) imaging system at the 99th ...
Tags: CT System, spectral detector
The US Food and Drug Administration (FDA) has approved Vifor Pharma's hyperphosphatemia drug Velphoro for the control of serum phosphorus levels in patients with Chronic Kidney Disease (CKD) on dialysis. Approval of Velphor, which is an ...
Tags: Drug, phosphate binder
Sumitomo Heavy Industries has obtained the US Food and Drug Administration (FDA) 510(k) clearance of its Proton Therapy System, a form of radiation therapy, which employs proton beams to kill cancer cells with better dose distribution in ...
Tags: Proton Therapy System, Sumitomo
Alfred Louie, a California-based food company, has halted production after the US Food and Drug Administration (FDA) inspectors found unsanitary conditions at the premises. Eastern District of California Judge Garland E. Burrell has ...
US-basedd VuCOMP has announced that M-Vu CAD, the first mammography CAD product clinically proven in a pivotal reader study, is available as a companion technology for the Siemens MAMMOMAT Inspiration PRIME Edition, MAMMOMAT Inspiration, ...
Tags: Healthcare, Health, Medicine
Amedica, a biomaterials company, has announced collaboration with Kyocera Industrial Ceramics, a ceramics producer, to manufacture medical devices from Amedica's silicon nitride biomaterial at Kyocera's Vancouver, Washington facility. ...
Tags: Health, Medicine, biomaterials
US-based Bruker has obtained 510(k) clearance from the US Food and Drug Administration (FDA) for its MALDI Biotyper CA system to identify Gram negative bacterial colonies cultured from human specimens. Bruker's MALDI Biotyper CA system ...
VBL Therapeutics has secured fast track status from the US Food and Drug Administration (FDA) for its lead oncology drug VB-111, for prolongation of survival in patients with Recurrent Glioblastoma Multiforme (rGBM). VB-111 was already ...